Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Last updated: June 9, 2025
Sponsor: Children's Oncology Group
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphocytic Leukemia, Acute

Lymphoproliferative Disorders

Leukemia

Treatment

Laboratory Biomarker Analysis

Dexrazoxane Hydrochloride

Cytarabine

Clinical Study ID

NCT03007147
AALL1631
AALL1631
2017-000705-20
U10CA180886
NCI-2016-01588
  • Ages 1-21
  • All Genders

Study Summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the requireddiagnostic bone marrow sample has been fulfilled

  • For patients who have not previously enrolled on APEC14B1 prior to enrollmenton AALL1631, a baseline diagnostic sample (or peripheral blood sample withblasts if marrow sample unavailable) must be available to develop an MRD probe

  • In addition, laboratory reports detailing evidence of BCR::ABL1 fusion orABL-class fusion must be submitted for rapid central review within 72 hours ofstudy enrollment

  • >= 1 year (365 days) and =< 21 years at ALL diagnosis

  • Ph+ (BCR::ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixedphenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]definition) with definitive evidence of BCR::ABL1 fusion by karyotype, fluorescencein situ hybridization (FISH) and/or molecular methodologies

  • ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-classfusions. ABL-class fusions are defined as those involving the following genes: ABL1,ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situhybridization ([FISH], e.g. using break-apart or colocalization signals probes),multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR),whole transcriptome or panel-based RNA-sequencing (e.g. TruSight RNA Pan-CancerPanel; Illumina, San Diego, California [CA], United States of America [USA] orsimilar)

  • Ph+ patients must have previously started Induction therapy, which includesvincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/orother standard cytotoxic chemotherapy

  • Ph+ patients have not received more than 14 days of multiagent Induction therapybeginning with the first dose of vinCRIStine

  • Ph+ patients may have started imatinib prior to study entry but have not receivedmore than 14 days of imatinib

  • ABL-class fusion patients must have previously completed the 4 or 5 weeks ofmultiagent Induction chemotherapy (Induction IA phase)

  • ABL-class fusion patients may have started imatinib during Induction IA, at the sametime of or after the first vinCRIStine dose

  • Patients must have a performance status corresponding to Eastern CooperativeOncology Group (ECOG) scores of 0, 1, or 2

  • Direct bilirubin =< 2.0 mg/dL

  • Shortening fraction of >= 27% by echocardiogram

  • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram

  • Corrected QT interval, QTc < 480 msec

  • Note: Repeat echocardiogram and electrocardiogram are not required if they wereperformed at or after initial ALL diagnosis, before study enrollment

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, asfollows:

  • 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)

  • 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)

  • 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)

  • 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)

  • 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)

  • >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

Exclusion

Exclusion Criteria:

  • Known history of chronic myelogenous leukemia (CML)

  • ALL developing after a previous cancer treated with cytotoxic chemotherapy

  • Active, uncontrolled infection, or active systemic illness that requires ongoingvasopressor support or mechanical ventilation

  • Down syndrome

  • Pregnancy and breast feeding

  • Female patients who are pregnant since fetal toxicities and teratogenic effectshave been noted for several of the study drugs. A pregnancy test is requiredfor female patients of childbearing potential

  • Lactating females who plan to breastfeed their infants

  • Sexually active patients of reproductive potential who have not agreed to usean effective contraceptive method for the duration of treatment according toprotocol

  • Patients with congenital long QT syndrome, history of ventricular arrhythmias orheart block

  • Prior treatment with dasatinib, or any TKI other than imatinib

Study Design

Total Participants: 475
Treatment Group(s): 24
Primary Treatment: Laboratory Biomarker Analysis
Phase: 3
Study Start date:
August 08, 2017
Estimated Completion Date:
September 30, 2027

Study Description

PRIMARY OBJECTIVE:

I. To compare disease-free survival (DFS) of standard risk (SR) pediatric Philadelphia chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate (imatinib) combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy backbone or the more intensive European (Es)PhALL chemotherapy backbone.

SECONDARY OBJECTIVES:

I. To compare DFS of SR pediatric Ph+ and ABL-class fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

II. To determine the feasibility of administration of imatinib after allogeneic hematopoietic stem cell transplantation (HSCT) in high risk (HR) Ph+ ALL patients.

III. To determine event-free survival (EFS) of HR pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.

IV. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients between the two randomized arms.

V. To evaluate EFS and overall survival (OS) of all eligible Ph+ALL patients enrolled on the study.

VI. To evaluate OS in SR Ph+ ALL patients. VII. To evaluate OS in HR Ph+ ALL patients. VIII. To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the study.

EXPLORATORY OBJECTIVES:

I. To describe the toxicities associated with post-HSCT administration of imatinib in HR Ph+ALL patients.

II. To evaluate the long-term toxicities in SR Ph+ ALL patients treated with chemotherapy plus imatinib (no transplant), overall and between both randomized arms.

III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at various time points during therapy.

IIIa. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals post-HSCT and explore the association of these measurements with long-term outcome.

IIIb. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) assay and next generation sequencing (NGS) assays.

IV. To determine and validate if IKZF1 deletions alone (IKZF1del) or with other transcription factor deletions (ie, IKZF1 plus subtype [IKZF1plus]) or other identified genetic lesions predict poor outcomes in Ph+/ABL-class Ph-like ALL in patients treated on AALL1631.

V. To determine the frequency and prognostic significance of p190 and p210 BCR::ABL1 fusion variants in pediatric Ph+ ALL/ABL-class Ph-like ALL.

VI. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine and methotrexate) during the maintenance phase in SR Ph+ ALL patients.

VIa. To identify factors associated with poor adherence. VIb. To determine association between relapse risk and adherence to each oral chemotherapeutic agent (separately and combined).

VII. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and identify factors associated with poor adherence.

VIII. To compare DFS of SR ABL-class fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

IX. To determine the potential therapeutic impact of major secondary events via pharmacologic inhibitor screens in existing/engineered cell models of Ph+ and ABL-class Ph-like ALL harboring secondary events and to test the in vivo activity of the most compelling candidate compounds from pilot studies using patient-derived xenograft (PDX) models established from Ph+ and ABL-class Ph-like ALL samples collected from patients treated on AALL1631.

X. To decipher the molecular and cellular heterogeneity of chronic myelogenous leukemia (CML)-like versus typical Ph+ ALL via single-cell genomics and functional assays and investigate CML-like phenotypes via single-cell ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) sequencing to identify distinct transcriptomic and mutational profiles that will provide novel opportunities for diagnostic and therapeutic interventions.

OUTLINE:

INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days 1-14.

INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22, daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate intrathecally (IT) on day 29.

INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or subcutaneously (SC) on days 3-6, 10-13, 17-20, and 24-27, and methotrexate IT on days 10 and 24.

POST-INDUCTION THERAPY: Patients classified as standard risk are randomized to 1 of 2 arms. Patients with high risk are assigned to Arm C.

ARM A:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6, dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4, leucovorin calcium or levoleucovorin PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and pegaspargase or calaspargase pegol IV over 1-2 hours on day 5, and filgrastim SC or IV on days 7-11 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin calcium or levoleucovorin PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 15 minutes and daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6, and filgrastim SC or IV on days 7-11 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high dose cytarabine IV over 3 hours on days 1-3, dexamethasone PO BID or IV on days 1-5, etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6, and filgrastim SC or IV on days 7-11 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 15 minutes, and doxorubicin IV over 3-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63, cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV over 1-30 minutes or SC on days 38-41 and 45-48, and methotrexate IT on days 38 and 45in the absence of disease progression or unexpected toxicity.

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28, methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 15 minutes, and doxorubicin IV over 3-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49, cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the absence of disease progression or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO once weekly (QW) and IT on days 1 and 43 of cycles 1, 2, and 3, and mercaptopurine PO on days 1-84. Cycles with imatinib mesylate and mercaptopurine repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of disease progression or unexpected toxicity.

ARM B:

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63, vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin calcium or levoleucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 15 minutes, and doxorubicin IV over 3-15 minutes on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or IM on day 4 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 43 in the absence of disease progression or unexpected toxicity.

INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 23 in the absence of disease progression or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV for cycle 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for cycle 1 and 2). Cycles repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of disease progression or unexpected toxicity.

ARM C:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine, therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone, leucovorin calcium or levoleucovorin, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A Consolidation Block 1, and filgrastim SC or IV on day 7 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine, therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate, ifosfamide, leucovorin calcium or levoleucovorin, dexrazoxane hydrochloride, daunorubicin hydrochloride, pegaspargase or calaspargase pegol, and filgrastim as Arm A Consolidation Block 2 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide, methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase or calaspargase pegol, and filgrastim as in Arm A Consolidation Block 3, and high dose cytarabine IV over 3 hours on days 1-2 in the absence of disease progression or unexpected toxicity.

HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm A.

POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every year for 3 years.

Connect with a study center

  • John Hunter Children's Hospital

    Hunter Regional Mail Centre, New South Wales 2310
    Australia

    Site Not Available

  • John Hunter Children's Hospital

    Newcastle, New South Wales 2310
    Australia

    Site Not Available

  • 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

  • Queensland Children's Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Princess Margaret Hospital for Children

    Perth, Western Australia 6008
    Australia

    Site Not Available

  • St. Anna Children's Hospital

    Vienna, 1090
    Austria

    Site Not Available

  • Universitätsklinik Eppendorf

    Vienna, 20246
    Austria

    Site Not Available

  • Hospitals Leuven

    Leuven, Flemish Brabant 3000
    Belgium

    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

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • 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

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • 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

  • Jim Pattison Children's Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Site Not Available

  • 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

  • Hospital Roberto del Rio-Universidad de Chile

    Santiago,
    Chile

    Site Not Available

  • The Chinese University of Hong Kong

    Hong Kong,
    China

    Site Not Available

  • The Chinese University of Hong Kong / Prince of Wales Hospital, Department of Pediatrics

    Shatin Hong Kong,
    China

    Site Not Available

  • University Hospital Motol

    Praha, 15018, 5-Motol
    Czechia

    Site Not Available

  • University Hospital Motol

    Praha 5-Motol,
    Czechia

    Site Not Available

  • Tampere University Hospital

    Tampere, 33521
    Finland

    Site Not Available

  • CHU Hopital Sud

    Rennes, 35203
    France

    Site Not Available

  • Unite d'hemato-oncologie et greffes de moelle/ CHU Hopital Sud

    Rennes Cedex 2,
    France

    Site Not Available

  • University Medical Center

    Schleswig-Holstein, Campus Kiel D-24105 Diel
    Germany

    Site Not Available

  • University Medical Center chleswig- Campus Kiel

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • University Medical Center chleswig- Campus Kiel

    Kiel,, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitatsklinik Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Universitätsklinik Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • University Medical Center Schleswig- Campus Kiel

    Kiel, Schleswig-Holstein, 24105
    Germany

    Site Not Available

  • University Medical Center Chleswig-Campus Kiel

    Schleswig,
    Germany

    Site Not Available

  • Hong Kong Children's Hospital

    Kowloon Bay, Kowloon
    Hong Kong

    Site Not Available

  • Schneider Children's Medical Center of Israe

    Petah-Tikva, Central District 4920235
    Israel

    Site Not Available

  • Schneider Children's Medical Center of Israel

    Petah-Tikva, Central District 4920235
    Israel

    Site Not Available

  • Schneider Children's Medical Center of Israel

    Petah-Tikva,, Central District 4920235
    Israel

    Site Not Available

  • Clinica Pediatrica Università Milano-Bicocca

    Via Pergolesi, Monza 20900
    Italy

    Site Not Available

  • Clinica Pediatrica Universita Milano - Bicocca

    Monza,
    Italy

    Active - Recruiting

  • Clinica Pediatrica Universita Milano-Biocca

    Monza, 20900
    Italy

    Active - Recruiting

  • Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM

    Monza, 20900
    Italy

    Site Not Available

  • Prof Andrea Biondi

    Monza,
    Italy

    Site Not Available

  • Princess Maxima Center for Pediatric Oncology

    Utrecht,
    Netherlands

    Site Not Available

  • Princess Máxima Center for Pediatric Oncology

    Utrecht, 3584 CT
    Netherlands

    Site Not Available

  • Starship Children's Hospital

    Grafton, Auckland 1145
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Site Not Available

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726
    Puerto Rico

    Site Not Available

  • San Jorge Children's Hospital

    San Juan, 00912
    Puerto Rico

    Site Not Available

  • University Pediatric Hospital

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211
    Saudi Arabia

    Site Not Available

  • Skane University Hospital

    Lund, Scania 22185
    Sweden

    Site Not Available

  • Prof. Dr. Nicole

    Zurich, CH8032
    Switzerland

    Site Not Available

  • University Children's Hospital

    Zurich, CH8032
    Switzerland

    Site Not Available

  • University Children's Hospital

    Zurich,, CH8032
    Switzerland

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • 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

  • Providence Alaska Medical Center

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • 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

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591
    United States

    Site Not Available

  • 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

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Kaiser Permanente-Oakland

    Oakland, California 94611
    United States

    Site Not Available

  • 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

  • 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

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

  • Miami Cancer Institute

    Miami, Florida 33176
    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

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Site Not Available

  • Sacred Heart Hospital

    Pensacola, Florida 32504
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

  • 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

  • Atrium Health Navicent

    Macon, Georgia 31201
    United States

    Site Not Available

  • Medical Center of Central Georgia

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho 83712
    United States

    Site Not Available

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    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

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • 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

  • 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

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • 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

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889-5600
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • 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

  • 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

    Site Not Available

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan 48236
    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

    Active - Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • Beaumont Children's Hospital-Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Corewell Health Children's

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • 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

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Columbia Regional

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • 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

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • 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

    Site Not Available

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • 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

  • Jersey Shore Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

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

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • 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

  • Presbyterian Hospital

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • 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

    Active - Recruiting

  • 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

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

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

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • 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

  • 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

    Site Not Available

  • 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

  • Sanford Broadway Medical Center

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Legacy Emanuel Children's Hospital

    Portland, Oregon 97227
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prisma Health Richland Hospital

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota 57117-5134
    United States

    Site Not Available

  • 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

    Site Not Available

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center-Amarillo

    Amarillo, Texas 79106
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Covenant Children's Hospital

    Lubbock, Texas 79410
    United States

    Site Not Available

  • UMC Cancer Center / UMC Health System

    Lubbock, Texas 79415
    United States

    Site Not Available

  • Children's Hospital of San Antonio

    San Antonio, Texas 78207
    United States

    Site Not Available

  • 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

    Site Not Available

  • Scott and White Memorial Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • University of Vermont and State Agricultural College

    Burlington, Vermont 05405
    United States

    Site Not Available

  • 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

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Carilion Children's

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • 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

    Site Not Available

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • West Virginia University Healthcare

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • 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

    Active - Recruiting

  • 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

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