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A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapse of Acute Lymphoblastic Leukemia

Status
Active
Cancer Type
Acute Lymphoblastic Leukemia
Leukemia
Lymphoma
Trial Phase
Phase I
Eligibility
1 - 21 Years, Male and Female
Study Type
Treatment
NCD ID
NCT02879643
Protocol IDs
T2012-002 (primary)
NCI-2016-01398
Study Sponsor
Therapeutic Advances in Childhood Leukemia Consortium

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).

Objectives

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.
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