A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.
Timeline
- Start
- 2015-12-30
- Primary completion
- 2020-04-24
- Completion
- 2020-04-24
Outcome
Missed primary endpoint
Stopped: “The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.”
registry analysis (superiority test); Placebo Plus Cytarabine vs Idasanutlin Plus Cytarabine; p = 0.5752; Hazard Ratio (HR) 1.08 (95% CI 0.81 to 1.45); Log Rank NCT02545283 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Idasanutlin | Small molecule | 300 mg | Oral |
| Background | Cytarabine | Small molecule | 1 g | Intravenous |