TACL-T2012-002: Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL

Patients must have relapsed Acute Lymphoblastic Leukemia (ALL).

Description

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). This study will utilize Marqibo® as a replacement for standard vincristine in combination with UK ALL R3 induction 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.

Eligibility Criteria

• Ages eligible for study: 1 year to 21 years (Child, Adult)
• Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) with ≥ 5% blasts in the bone marrow (M2 or M3), with or without extramedullary disease (excluding active Central Nervous System 3 involvement).
• Patients with first relapse must have an M3 marrow to be eligible.

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.

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Contact

Eric S. Schafer, MD, MHS
Local Principal Investigator
Texas Children’s Cancer and Hematology Center