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
Acute Lymphoblastic Leukemia
1 - 21 Years, Male and Female
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.