SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission
Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
This is a non-randomized open label multi-center study. Patients who are in their first
complete remission (CR) following induction therapy will be treated with SL-401, which will
be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or
more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be
treated with SL-401 at 3 dose levels. During Stage 2, up to approximately 20 patients with
minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated
dose or maximum tested dose in which multiple dose-limiting toxicities are not observed
(identified in Stage 1).