Vincristine Sulfate Liposome Injection (Marqibo ) in Combination With UK ALL R3 Induction Chemotherapy for Children Adolescents and Young Adults With Relapsed ALL

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    36
  • sponsor
    Therapeutic Advances in Childhood Leukemia Consortium
Updated on 6 May 2020
Investigator
Ellynore Florendo
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
+32 other location
graft versus host disease
lymphoid leukemia
tyrosine
lymphoma
philadelphia chromosome
hydroxyurea
acute leukemia
methotrexate
cytarabine
rituximab
lymphoblastic lymphoma
vincristine
ejection fraction
granulocyte colony stimulating factor
minimal residual disease
asparaginase
residual tumor
dexamethasone
mitoxantrone
ara-c
anthracyclines
left ventricular fractional shortening

Summary

This is a pilot study utilizing Marqibo (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).

Description

This study will utilize Marqibo as a replacement for standard vincristine in combination with chemotherapy for children with relapsed ALL. The hypothesis is that the incorporation of Marqibo with combination chemotherapy will be safe and feasible. In the context of this pilot study, overall outcomes and efficacy will be a secondary objective. It is hypothesized that data from this combination may show improved efficacy including, complete remission (CR), minimal residual disease (MRD) negativity, and progression free survival (PFS) rates and safety (i.e., neurotoxicity) in comparison to outcomes in historical regimens, including the UK ALL R3 with standard vincristine.

Details
Treatment Marqibo in combination with UK ALL R3, Marqibo
Clinical Study IdentifierNCT02879643
SponsorTherapeutic Advances in Childhood Leukemia Consortium
Last Modified on6 May 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 21 yrs?
Gender: Male or Female
Do you have any of these conditions: childhood ALL or Lymphocytic Leukemia, Acute?
Age
Patients must be 1 and 21 years of age at the time of enrollment
Diagnosis
Cohort A: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) or mixed phenotypic acute leukemia with 5% blasts in the bone marrow (M2 or M3), with or without extramedullary disease) or a diagnosis of lymphoblastic lymphoma
Cohorts B & C: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, or mixed phenotypic acute leukemia with any level of detectable disease (minimal residual disease level acceptable) with or without extramedullary disease
Performance Level -Karnofsky > 50% for patients > 16 years of age and Lansky >
% for patients 16 years of age
Prior Therapy
Patients must have recovered from the acute toxic effects ( Grade 2 or baseline) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, unless otherwise specified. Subjects with disease related cytopenias will be eligible
Patients must have relapsed or refractory disease after attaining at least a first remission. They may be in first to third relapse
Patients with Philadelphia chromosome t(9;22) positive disease must have received at least two prior tyrosine kinase inhibitors
Patients who have experienced their relapse after a Hematopoietic stem cell transplantation (HSCT) are eligible, provided they have no evidence of graft-versus-host disease (GVHD) and are at least 100 days post-transplant at the time of enrollment
Prior anthracycline lifetime cumulative exposure: Patients must have less than 320 mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline chemotherapy
Cohort A: Patients must have less than 320 mg/m2 (or 400 mg/m2 if prior cardioprotection) lifetime exposure of anthracycline chemotherapy (See Appendix 2 for anthracycline calculation worksheet)
Cohorts B & C: There is no limit on prior anthracycline exposure
Hematopoietic growth factors: It must have been at least seven days since the completion of therapy with granulocyte colony-stimulating factor (GCSF) or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta)
Biologic anti-neoplastic agents: At least seven days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond seven days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair or vice chair
Monoclonal antibodies: At least three half-lives (or 30 dayswhichever is longer) of the antibody must have elapsed after the last dose of monoclonal antibody. (e.g., Rituximab = 66 days, Epratuzumab = 69 days)
Immunotherapy: At least 30 days after the completion of any type of immunotherapy, e.g. tumor vaccines, chimeric antigen receptor T-cells
Recent prior chemotherapy: At least 10 days after standard vincristine and the completion of any type of chemotherapy induction regimen. At least 3 weeks after radiation therapy. At least 30 days after the completion of any investigational neoplastic agent is also required. An investigational agent is defined as any drug that is not approved and licensed for sale by the FDA for institutions in the United States, by Health Canada for institutions in Canada and by The Therapeutic Goods Administration for institutions in Australia
Exceptions
There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such; it is allowable to enroll a patient that has received IT Cytarabine (ARA-C), IT Methotrexate (MTX) or triple IT therapy within 14 days of enrollment as part of their evaluation to diagnose disease relapse. The IT therapy given within 14 days of initiation of protocol specified chemotherapy, may substitute for the day 1 IT in cohorts A and B
Subjects with rapidly progressive disease may receive hydroxyurea until they begin study therapy
Patients who relapse while on maintenance-type ALL therapy or are receiving maintenance therapy for disease stabilization will not require a wash-out period before entry into this study. However, there must be at least 10 days after any dose of standard vincristine
Renal and Hepatic Function
Renal function: Patient's serum creatinine must be 1.5 x institutional upper limit of normal (ULN) according to age. If the serum creatinine is greater than 1.5 times normal, the patient must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) 70milliliter/min/1.73m2. Alternatively, a 24-hour creatinine clearance may also be used
Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be < 5 x institutional upper limit of norm ULN. Total bilirubin must be 1.5 x ULN (except in the case of subjects with documented Gilbert's disease 5 ULN)
Cardiac Function
Patients must have a shortening fraction 27% or an ejection fraction 55% by echocardiogram, cardiac MRI or multigated acquisition scan (MUGA)
Reproductive Function
Female patients must not be pregnant and those of childbearing potential must have a negative urine or serum pregnancy test confirmed within one week prior to enrollment
Female patients with infants must agree not to breastfeed their infants while on this study
Male and female patients of childbearing potential must agree to use an effective method of contraception during the study

Exclusion Criteria

Patients will be excluded if they have isolated testicular disease
Patients will be excluded if they have previously received Marqibo
Patients will be excluded if they have a known allergy to any of the drugs
used in the study, with the exception that patients with an allergy to PEG-
asparaginase who can receive Erwinia asparaginase are eligible. Patients
unable to receive any formulation of asparaginase may only enroll on cohort C
Patients will be excluded if they have active, uncontrolled systemic fungal
bacterial, viral or other infection despite appropriate antibiotics or other
treatment
Patients who require azole antifungal agents will be excluded. Azoles must be
discontinued at least one week prior to the start of Marqibo
Patients will be excluded if there is a plan to administer non-protocol
chemotherapy, radiation therapy, another investigational agent or
immunotherapy during the study period
Patients with pre-existing, persistent grade 2 or greater sensory or motor
neuropathy from any cause will be excluded
Patients will be excluded if they have, significant concurrent disease
illness, psychiatric disorder or social issue that would compromise patient
safety or adherence with the protocol treatment or procedures or interfere
with consent, study participation, follow up, or interpretation of study
results.Patients with Down syndrome will not be eligible for enrollment on
Cohort A
Patients with a known history of human immunodeficiency virus (HIV) will will
be excluded due to the increased risk of complications such as severe
infection and unknown interaction of Marqibo with antiretroviral drugs
Active hepatitis B or C infection as defined by seropositive for hepatitis B
(hepatitis B surface antigen (HBsAg)) or hepatitis C and elevated liver
transaminases (defined as above the ULN per the institution normal ranges)
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