A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Last updated: February 20, 2026
Sponsor: Children's Oncology Group
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

Liposome-encapsulated Daunorubicin-Cytarabine

Biospecimen Collection

Computed Tomography

Clinical Study ID

NCT04293562
AAML1831
AAML1831
NCI-2020-00546
U10CA180886
  • Ages < 21
  • All Genders

Study Summary

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831

  • Patients must be less than 22 years of age at the time of study enrollment

  • Patient must be newly diagnosed with de novo AML according to the 2016 World HealthOrganization (WHO) classification with or without extramedullary disease

  • Patient must have 1 of the following:

  • >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)

  • In cases where extensive fibrosis may result in a dry tap, blastcount can be obtained from touch imprints or estimated from anadequate bone marrow core biopsy

  • < 20% bone marrow blasts with one or more of the genetic abnormalitiesassociated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)

  • A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or aWBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)

  • ARM C: Patient must be >= 2 years of age at the time of Late Callback

  • ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by MolecularOncology

  • ARM C: Patient does not have any congenital long QT syndrome or congenital heartblock

  • ARM C: Females of reproductive potential must agree to use effective contraceptionduring treatment and for at least 6 months after the last dose of gilteritinib

  • ARM C: Lactating women must agree not to breastfeed during treatment withgilteritinib and for 2 months after the last dose of gilteritinib

  • ARM C: Males of reproductive potential must agree to use effective contraceptionduring treatment and for at least 4 months after the last dose of gilteritinib

  • ARM D: Patient must be >= 2 years of age at the time of Late Callback

  • ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activatingmutations as reported by Foundation Medicine

  • ARM D: Females of reproductive potential must agree to use effective contraceptionduring treatment and for at least 6 months after the last dose of gilteritinib

  • ARM D: Lactating women must agree not to breastfeed during treatment withgilteritinib and for 2 months after the last dose of gilteritinib

  • ARM D: Males of reproductive potential must agree to use effective contraceptionduring treatment and for at least 4 months after the last dose of gilteritinib

  • NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients whotransfer to Arm C or Arm D are not eligible

  • NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time ofenrollment

  • NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking

  • NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior todiagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mentalretardation)

  • NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that wouldprevent computer use or recognition of visual test stimuli

  • All patients and/or their parents or legal guardians must sign a written informedconsent

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion

Exclusion Criteria:

  • Fanconi anemia

  • Shwachman Diamond syndrome

  • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21

  • Telomere disorders

  • Germline predispositions known, or suspected by the treating physician to increaserisk of toxicity with AML therapy

  • Any concurrent malignancy

  • Juvenile myelomonocytic leukemia (JMML)

  • Philadelphia chromosome positive AML

  • Mixed phenotype acute leukemia

  • Acute promyelocytic leukemia

  • Acute myeloid leukemia arising from myelodysplasia

  • Therapy-related myeloid neoplasms

  • Patients with persistent cardiac dysfunction prior to enrollment, defined asejection fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EFunavailable, shortening fraction (SF) < 24%. *Note: if clinically safe and feasible,repeat echocardiogram is strongly advised in order to confirm cardiac dysfunctionfollowing clinical stabilization, particularly if occurring in the setting of sepsisor other transient physiologic stressor. If the repeat echocardiogram demonstratesan EF >= 50%, the patient is eligible to enroll and may receive ananthracycline-containing Induction regimen

  • Administration of prior anti-cancer therapy except as outlined below:

  • Hydroxyurea

  • All-trans retinoic acid (ATRA)

  • Corticosteroids (any route)

  • Intrathecal therapy given at diagnosis

  • In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should beavoided from the time of enrollment until it is determined whether the patientwill receive gilteritinib. Patients receiving gilteritinib will be required toavoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration ofthe study treatment

  • Female patients who are pregnant since fetal toxicities and teratogenic effects havebeen noted for several of the study drugs. A pregnancy test is required for femalepatients of childbearing potential

  • Lactating females who plan to breastfeed their infants

  • Sexually active patients of reproductive potential who have not agreed to use aneffective contraceptive method for the duration of their study participation

  • ARM D: Patient does not have any congenital long QT syndrome or congenital heartblock

Study Design

Total Participants: 1186
Treatment Group(s): 22
Primary Treatment: Liposome-encapsulated Daunorubicin-Cytarabine
Phase: 3
Study Start date:
July 21, 2020
Estimated Completion Date:
June 30, 2029

Study Description

PRIMARY OBJECTIVE:

I. To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML) without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with CPX-351 and GO.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).

II. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib fumarate (gilteritinib) in combination with DA-GO (Arm AC).

III. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD and BD).

IV. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in patients with FLT3/ITD and FLT3/TKD mutations (Arm AC/Arm BC/Arm AD/Arm BD).

V. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (allelic ratio [AR] > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib versus (vs) CPX-GO-gilteritinib (Arm AC vs Arm BC).

VI. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).

VII. To compare the changes in echocardiography-derived measures of cardiac function, including left ventricular ejection fraction (EF) and global longitudinal strain (GLS), throughout AML therapy in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.

VIII. Determine if early changes in sensitive echocardiographic measures of cardiac function (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant AML receiving therapy on Arms A or B.

IX. To compare longitudinal acute changes in neuropsychological functioning and neurocognitive late effects between those with central nervous system (CNS) disease and those without CNS disease and between those treated with hematopoietic stem cell transplant (HSCT) and those treated with chemotherapy only for patients on Arms A and B.

X. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving standard induction with dexrazoxane hydrochloride (dexrazoxane) vs. CPX-351 in the context of gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies from that observed in non-FLT3 mutant AML without gilteritinib exposure.

EXPLORATORY OBJECTIVES:

I. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR) FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in combination with DA-GO (Arm AC with AR > 0.4).

II. To estimate the EFS, OS, and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with DA-GO (Arm AC).

III. Compare the changes in high sensitivity troponin and natriuretic peptide elevations throughout AML therapy, as measured at the end of each chemotherapy course, in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.

IV. Quantify the association of host factors (age, sex, body mass index [BMI], race), treatment exposures (cumulative anthracycline dose, anthracycline arm, hematopoietic stem cell transplant vs. chemotherapy alone), early declines in GLS, and elevations in cardiac biomarkers (cTnT and NT-proBNP) with subsequent LVSD.

V. To describe the rates of CNS disease utilizing an updated strategy for diagnosing and defining CNS disease in pediatric AML.

VI. To describe the rates of CNS relapse (both isolated CNS and combined bone marrow/CNS) when utilizing this updated strategy as well as changing CNS prophylaxis and treatment to include triple intrathecal chemotherapy.

VII. To describe the rate of bone marrow measurable residual disease, detected by multi-dimensional flow cytometry, prior to hematopoietic stem cell transplant (HSCT).

VIII. To describe plasma metabolomics that may impact efficacy, toxicity, and/or pharmacokinetics of allogeneic HSCT.

IX. To estimate the prevalence of non-risk stratifying cytogenetic/molecular variants and assess their impact on outcome in childhood AML.

X. To describe the pharmacokinetic parameters of plasma cytarabine and daunorubicin after CPX-351 administration to pediatric and young adult patients with new diagnosis of AML.

XI. To describe the pharmacokinetic parameters of orally administered gilteritinib when administered to pediatric and young adult patients with new diagnosis of AML.

XII. To describe the pharmacodynamic parameters of gilteritinib using the FLT3 plasma inhibitory activity assay (PIA) when administered to children and young adults with new diagnosis of AML and FLT3 mutations.

XIII. To estimate OS in patients with FLT3/ITD+ AML (AR > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib or CPX-351-GO-gilteritinib (Separate analyses will be conducted for Arm AC vs Arm BC).

OUTLINE: Patients are randomized to either Arm A or B and assigned to Arm C or D based on FLT3 testing results. As of 11/19/24 arms B, BC and BD are closed and new patients receive treatment in Arm A Low Risk Group 2 Induction 1 or Arm A High Risk Induction 1, and then assigned to arm AC or AD per FLT3 results.

Risk group assignments are calculated based on cytogenetic, molecular and genomic findings (details in protocol)

  1. Low Risk 1

  2. Low Risk 2

  3. High Risk

    TREATMENT FOR PATIENTS WITHOUT FLT3 MUTATIONS:

    ARM A LOW RISK GROUP 1:

    INDUCTION 1: Patients receive cytarabine intravenously (IV) over 1-30 minutes every 12 hours (Q12H) on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate intrathecally (IT), therapeutic hydrocortisone (hydrocortisone) IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT once weekly (QW) starting on day 8 for 4-6 weeks (may continue into Induction 2) until the cerebral spinal fluid (CSF) is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi intramuscularly (IM) on days 2 and 9 or IV over 1-2 hours on days 2 and 9.

    ARM B LOW RISK GROUP 1:

    INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM on days 2 and 9 or IV over 1-2 hours on days 2 and 9.

    ARM A LOW RISK GROUP 2:

    INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and dexrazoxane IV over 15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15 minutes on days 3-6.

    INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM on days 2 and 9 or IV over 1-2 hours on days 2 and 9.

    ARM B LOW RISK GROUP 2:

    INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and dexrazoxane IV over 15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15 minutes on days 3-6.

    INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM on days 2 and 9 or IV over 1-2 hours on days 2 and 9.

    ARM A HIGH RISK GROUP:

    INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    ARM B HIGH RISK GROUP:

    INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

    INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    TREATMENT FOR PATIENTS WITH FLT3/ITD MUTATIONS (ITD AR > 0.1):

    ARM AC LOW RISK GROUP 2:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally (PO)/nasogastric (NG)/gastrostomy (G)-tube once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO/NG/G-tube QD on days 7-27.

    INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours, and gilteritinib PO/NG/G-tube QD on days 10-30.

    POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    ARM BC LOW RISK GROUP 2:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO/NG/G-tube QD on days 7-27.

    INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours, and gilteritinib PO/NG/G-tube QD on days 10-30.

    POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    ARM AC HIGH RISK GROUP:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    ARM BC HIGH RISK GROUP:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    TREATMENT FOR NON-ITD FLT3 ACTIVATING MUTATIONS:

    ARM AD LOW RISK GROUP 2:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO/NG/G-tube QD on days 7-27.

    INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours, and gilteritinib PO/NG/G-tube QD on days 10-30.

    POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    ARM BD LOW RISK GROUP 2:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO/NG/G-tube QD on days 6-26.

    INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO/NG/G-tube QD on days 7-27.

    INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours, and gilteritinib PO/NG/G-tube QD on days 10-30.

    POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO/NG/G-tube QD on days 1-365.

    ARM AD HIGH RISK GROUP:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO/NG/G-tube QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO/NG/G-tube QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO or NG or G tube QD on days 1-365.

    ARM BD HIGH RISK GROUP:

    CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

    INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-31.

    INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

    HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

    POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO or NG or G tube QD on days 1-365.

    NOTE: During Induction 2 or Intensification 2, patients in Arms A and B with left ventricular systolic dysfunction receive a replacement course of high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9, and asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours. Patients in Arms AC, BC, AD, and BD receive treatment as in Arms A and B and also receive gilteritinib PO QD on days 10-30 (Induction 2) or days 10-30 (Intensification 2).

    OPTIONAL NEUROCOGNITIVE STUDY:

    Patients may complete the Cogstate assessment battery at the end of Induction 1, at the end of therapy, and at 9 and 60 months post-enrollment.

Connect with a study center

  • Sydney Children's Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Sydney Children's Hospital

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane 2207259, Queensland 2152274 4101
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth 2063523, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Alberta Children's Hospital

    Calgary 5913490, Alberta 5883102 T3B 6A8
    Canada

    Active - Recruiting

  • University of Alberta Hospital

    Edmonton 5946768, Alberta 5883102 T6G 2B7
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • British Columbia Children's Hospital

    Vancouver 6173331, British Columbia 5909050 V6H 3V4
    Canada

    Active - Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg 6183235, Manitoba 6065171 R3E 0V9
    Canada

    Active - Recruiting

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax 6324729, Nova Scotia 6091530 B3K 6R8
    Canada

    Active - Recruiting

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Children's Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943 L8N 3Z5
    Canada

    Suspended

  • Kingston Health Sciences Centre

    Kingston 5992500, Ontario 6093943 K7L 2V7
    Canada

    Active - Recruiting

  • Children's Hospital

    London 6058560, Ontario 6093943 N6A 5W9
    Canada

    Active - Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa 6094817, Ontario 6093943 K1H 8L1
    Canada

    Active - Recruiting

  • Hospital for Sick Children

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec H3H 1P3
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal 6077243, Quebec 6115047 H3T 1C5
    Canada

    Active - Recruiting

  • The Montreal Children's Hospital of the MUHC

    Montreal 6077243, Quebec 6115047 H3H 1P3
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke 6146143, Quebec 6115047 J1H 5N4
    Canada

    Active - Recruiting

  • Jim Pattison Children's Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Jim Pattison Children's Hospital

    Saskatoon 6141256, Saskatchewan 6141242 S7N 0W8
    Canada

    Active - Recruiting

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Quebec

    Quebec, G1V 4G2
    Canada

    Active - Recruiting

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Québec 6325494, G1V 4G2
    Canada

    Active - Recruiting

  • University Pediatric Hospital

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • University Pediatric Hospital

    San Juan 4568127, 00926
    Puerto Rico

    Active - Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • USA Health Strada Patient Care Center

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Children's Hospital of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • USA Health Strada Patient Care Center

    Mobile 4076598, Alabama 4829764 36604
    United States

    Active - Recruiting

  • Banner Children's at Desert

    Mesa, Arizona 85202
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Banner University Medical Center - Tucson

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Banner Children's at Desert

    Mesa 5304391, Arizona 5551752 85202
    United States

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Active - Recruiting

  • Banner University Medical Center - Tucson

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock 4119403, Arkansas 4099753 72202-3591
    United States

    Active - Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California 90242
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Mattel Children's Hospital UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Kaiser Permanente-Oakland

    Oakland, California 94611
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Rady Children's Hospital - San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • UCSF Medical Center-Mission Bay

    San Francisco, California 94158
    United States

    Site Not Available

  • Santa Barbara Cottage Hospital

    Santa Barbara, California 93102
    United States

    Site Not Available

  • Kaiser Permanente Downey Medical Center

    Downey 5343858, California 5332921 90242
    United States

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Loma Linda University Medical Center

    Loma Linda 5367696, California 5332921 92354
    United States

    Active - Recruiting

  • Miller Children's and Women's Hospital Long Beach

    Long Beach 5367929, California 5332921 90806
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Active - Recruiting

  • Mattel Children's Hospital UCLA

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Valley Children's Hospital

    Madera 5369568, California 5332921 93636
    United States

    Active - Recruiting

  • Kaiser Permanente-Oakland

    Oakland 5378538, California 5332921 94611
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland 5378538, California 5332921 94609
    United States

    Active - Recruiting

  • Children's Hospital of Orange County

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Rady Children's Hospital - San Diego

    San Diego 5391811, California 5332921 92123
    United States

    Active - Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara 5392952, California 5332921 93102
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Active - Recruiting

  • Yale University

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Active - Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Alfred I duPont Hospital for Children

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Active - Recruiting

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Children's National Medical Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Active - Recruiting

  • Broward Health Medical Center

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Palms West Radiation Therapy

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Sacred Heart Hospital

    Pensacola, Florida 32504
    United States

    Suspended

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Saint Mary's Hospital

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Saint Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Broward Health Medical Center

    Fort Lauderdale 4155966, Florida 4155751 33316
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers 4155995, Florida 4155751 33908
    United States

    Active - Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville 4156404, Florida 4155751 32610
    United States

    Active - Recruiting

  • University of Florida Health Science Center - Gainesville

    Gainesville 4156404, Florida 4155751 32610
    United States

    Active - Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville 4160021, Florida 4155751 32207
    United States

    Active - Recruiting

  • Palms West Radiation Therapy

    Loxahatchee Groves 4162948, Florida 4155751 33470
    United States

    Site Not Available

  • Nicklaus Children's Hospital

    Miami 4164138, Florida 4155751 33155
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Active - Recruiting

  • Arnold Palmer Hospital for Children

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Nemours Children's Hospital

    Orlando 4167147, Florida 4155751 32827
    United States

    Active - Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola 4168228, Florida 4155751 32504
    United States

    Active - Recruiting

  • Sacred Heart Hospital

    Pensacola 4168228, Florida 4155751 32504
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    St. Petersburg 4171563, Florida 4155751 33701
    United States

    Active - Recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Saint Mary's Medical Center

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Augusta University Medical Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Active - Recruiting

  • Augusta University Medical Center

    Augusta 4180531, Georgia 4197000 30912
    United States

    Active - Recruiting

  • Memorial Health University Medical Center

    Savannah 4221552, Georgia 4197000 31404
    United States

    Active - Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu 5856195, Hawaii 5855797 96826
    United States

    Active - Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho 83712
    United States

    Site Not Available

  • Saint Luke's Cancer Institute - Boise

    Boise 5586437, Idaho 5596512 83712
    United States

    Active - Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Saint Jude Midwest Affiliate

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Lurie Children's Hospital-Chicago

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Illinois

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Active - Recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Active - Recruiting

  • Advocate Children's Hospital-Park Ridge

    Park Ridge 4905367, Illinois 4896861 60068
    United States

    Active - Recruiting

  • Saint Jude Midwest Affiliate

    Peoria 4905687, Illinois 4896861 61637
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield 4250542, Illinois 4896861 62702
    United States

    Active - Recruiting

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Active - Recruiting

  • Riley Hospital for Children

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Blank Children's Hospital

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Blank Children's Hospital

    Des Moines 4853828, Iowa 4862182 50309
    United States

    Active - Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Norton Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Kentucky/Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

  • Norton Children's Hospital

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • Children's Hospital New Orleans

    New Orleans, Louisiana 70118
    United States

    Active - Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Children's Hospital New Orleans

    New Orleans 4335045, Louisiana 4331987 70118
    United States

    Active - Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Active - Recruiting

  • Eastern Maine Medical Center

    Bangor, Maine 04401
    United States

    Site Not Available

  • Maine Children's Cancer Program

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Eastern Maine Medical Center

    Bangor 4957280, Maine 4971068 04401
    United States

    Active - Recruiting

  • Maine Children's Cancer Program

    Scarborough 4977882, Maine 4971068 04074
    United States

    Active - Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889-5600
    United States

    Site Not Available

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore 4347778, Maryland 4361885 21215
    United States

    Active - Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Active - Recruiting

  • Walter Reed National Military Medical Center

    Bethesda 4348599, Maryland 4361885 20889-5600
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Children's Hospital

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Tufts Children's Hospital

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • UMass Memorial Medical Center - University Campus

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Active - Recruiting

  • C S Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Ascension Saint John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • Michigan State University Clinical Center

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Bronson Methodist Hospital

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • Beaumont Children's Hospital-Royal Oak

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Corewell Health Children's

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • C S Mott Children's Hospital

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Children's Hospital of Michigan

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit 4990729, Michigan 5001836 48236
    United States

    Site Not Available

  • Michigan State University

    East Lansing 4991640, Michigan 5001836 48823
    United States

    Site Not Available

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Active - Recruiting

  • Bronson Methodist Hospital

    Kalamazoo 4997787, Michigan 5001836 49007
    United States

    Active - Recruiting

  • Corewell Health Children's

    Royal Oak 5007804, Michigan 5001836 48073
    United States

    Active - Recruiting

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis 5037649, Minnesota 5037779 55404
    United States

    Active - Recruiting

  • University of Minnesota/Masonic Cancer Center

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson 4431410, Mississippi 4436296 39216
    United States

    Active - Recruiting

  • Columbia Regional

    Columbia, Missouri 65201
    United States

    Site Not Available

  • University of Missouri Children's Hospital

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Cardinal Glennon Children's Medical Center

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Missouri Children's Hospital

    Columbia 4381982, Missouri 4398678 65212
    United States

    Suspended

  • Children's Mercy Hospitals and Clinics

    Kansas City 4393217, Missouri 4398678 64108
    United States

    Active - Recruiting

  • Cardinal Glennon Children's Medical Center

    St Louis 4407066, Missouri 4398678 63104
    United States

    Site Not Available

  • Mercy Hospital Saint Louis

    St Louis 4407066, Missouri 4398678 63141
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Children's Hospital and Medical Center of Omaha

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Active - Recruiting

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada 89109
    United States

    Suspended

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Suspended

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas 5506956, Nevada 5509151 89135
    United States

    Active - Recruiting

  • Summerlin Hospital Medical Center

    Las Vegas 5506956, Nevada 5509151 89144
    United States

    Active - Recruiting

  • Sunrise Hospital and Medical Center

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Suspended

  • University Medical Center of Southern Nevada

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Suspended

  • Renown Regional Medical Center

    Reno 5511077, Nevada 5509151 89502
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • Saint Peter's University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112
    United States

    Site Not Available

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick 5101717, New Jersey 5101760 08903
    United States

    Active - Recruiting

  • Saint Peter's University Hospital

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Newark Beth Israel Medical Center

    Newark 5101798, New Jersey 5101760 07112
    United States

    Active - Recruiting

  • Saint Joseph's Regional Medical Center

    Paterson 5102466, New Jersey 5101760 07503
    United States

    Active - Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque 5454711, New Mexico 5481136 87106
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Montefiore Medical Center - Moses Campus

    Bronx, New York 10467
    United States

    Site Not Available

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • NYU Winthrop Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Suspended

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYP/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • State University of New York Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Albany Medical Center

    Albany 5106834, New York 5128638 12208
    United States

    Active - Recruiting

  • Maimonides Medical Center

    Brooklyn 5110302, New York 5128638 11219
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island

    Mineola 5127134, New York 5128638 11501
    United States

    Active - Recruiting

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park 5128514, New York 5128638 11040
    United States

    Active - Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York 5128581, New York 5128638 10029
    United States

    Suspended

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • NYP/Weill Cornell Medical Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • University of Rochester

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Stony Brook University Medical Center

    Stony Brook 5139865, New York 5128638 11794
    United States

    Active - Recruiting

  • State University of New York Upstate Medical University

    Syracuse 5140405, New York 5128638 13210
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • New York Medical College

    Valhalla 5142090, New York 5128638 10595
    United States

    Active - Recruiting

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Mission Hospital

    Asheville 4453066, North Carolina 4482348 28801
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Active - Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Active - Recruiting

  • East Carolina University

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Sanford Broadway Medical Center

    Fargo 5059163, North Dakota 5690763 58122
    United States

    Active - Recruiting

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Dayton Children's Hospital

    Dayton, Ohio 45404
    United States

    Site Not Available

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Children's Hospital Medical Center of Akron

    Akron 5145476, Ohio 5165418 44308
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus 4509177, Ohio 5165418 43205
    United States

    Active - Recruiting

  • Dayton Children's Hospital

    Dayton 4509884, Ohio 5165418 45404
    United States

    Active - Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo 5174035, Ohio 5165418 43606
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • Legacy Emanuel Children's Hospital

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Legacy Emanuel Children's Hospital

    Portland 5746545, Oregon 5744337 97227
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Penn State Children's Hospital

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Lehigh Valley Hospital-Cedar Crest

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Active - Recruiting

  • Geisinger Medical Center

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Active - Recruiting

  • Penn State Children's Hospital

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Saint Christopher's Hospital for Children

    Philadelphia 4560349, Pennsylvania 6254927 19134
    United States

    Active - Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prisma Health Richland Hospital

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Prisma Health Richland Hospital

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Active - Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota 57117-5134
    United States

    Site Not Available

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls 5231851, South Dakota 5769223 57117-5134
    United States

    Active - Recruiting

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • T C Thompson Children's Hospital

    Chattanooga 4612862, Tennessee 4662168 37403
    United States

    Active - Recruiting

  • East Tennessee Childrens Hospital

    Knoxville 4634946, Tennessee 4662168 37916
    United States

    Active - Recruiting

  • The Children's Hospital at TriStar Centennial

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas 78723
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Medical City Dallas Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • El Paso Children's Hospital

    El Paso, Texas 79905
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Children's Hospital of San Antonio

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Scott and White Memorial Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Dell Children's Medical Center of Central Texas

    Austin 4671654, Texas 4736286 78723
    United States

    Active - Recruiting

  • Driscoll Children's Hospital

    Corpus Christi 4683416, Texas 4736286 78411
    United States

    Active - Recruiting

  • Medical City Dallas Hospital

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • El Paso Children's Hospital

    El Paso 5520993, Texas 4736286 79905
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Children's Hospital of San Antonio

    San Antonio 4726206, Texas 4736286 78207
    United States

    Active - Recruiting

  • Methodist Children's Hospital of South Texas

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Scott and White Memorial Hospital

    Temple 4735966, Texas 4736286 76508
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City 5780993, Utah 5549030 84113
    United States

    Active - Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont 05405
    United States

    Site Not Available

  • University of Vermont and State Agricultural College

    Burlington 5234372, Vermont 5242283 05405
    United States

    Active - Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia 23708-2197
    United States

    Site Not Available

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Carilion Children's

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Virginia Cancer Center

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Active - Recruiting

  • Naval Medical Center - Portsmouth

    Portsmouth 4779999, Virginia 6254928 23708-2197
    United States

    Active - Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond 4781708, Virginia 6254928 23298
    United States

    Active - Recruiting

  • Carilion Children's

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431
    United States

    Site Not Available

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane 5811696, Washington 5815135 99204
    United States

    Active - Recruiting

  • Madigan Army Medical Center

    Tacoma 5812944, Washington 5815135 98431
    United States

    Active - Recruiting

  • Mary Bridge Children's Hospital and Health Center

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

  • West Virginia University Charleston Division

    Charleston, West Virginia 25304
    United States

    Active - Recruiting

  • West Virginia University Charleston Division

    Charleston 4801859, West Virginia 4826850 25304
    United States

    Active - Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay 5254962, Wisconsin 5279468 54301
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield 5261969, Wisconsin 5279468 54449
    United States

    Active - Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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