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

Titre officiel

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

Sommaire:

Il s’agit d’une étude pilote évaluant le médicament Marqibo® (injection liposomique de sulfate de vincristine) combiné à la dexaméthasone, au mitoxantrone et à l’asparaginase (essai ALLR3 mené au R.-U.) pour le traitement de la leucémie lymphoblastique aiguë (LLA) récidivante.

Description de l'essai

Primary Outcome:

• Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability

Secondary Outcome:

• The response rate after treatment.

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.

Voir cet essai sur ClinicalTrials.gov