Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
Status:
Completed
Trial end date:
2010-08-08
Target enrollment:
Participant gender:
Summary
This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating
Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or
greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment
lines of anti-leukemia chemotherapy. The original enrollment target for this study was
approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.
The primary objective of this study was to evaluate:
- The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete
blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL
in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of
anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior
anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.