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NCT02545283 · ClinicalTrials.gov registry record · Phase 3
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT02545283: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02545283 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02545283, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study 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.
Primary Outcome
P53 tumor protein Wild Type (TP53 WT) population's Overall Survival was compared in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo. The study was terminated because of futility, therefore did not reach the planned end of the study.
Interventions
- OTHER Placebo
- DRUG Cytarabine
- DRUG Idasanutlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2015-12-30 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 3 |
Why NCT02545283 stopped before completion
NCT02545283 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02545283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02545283 about?
NCT02545283 is a clinical study titled "A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)". 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 in...
What is the current status of trial NCT02545283?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2015-12-30. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT02545283?
The interventions under investigation include: Placebo (OTHER), Cytarabine (DRUG), Idasanutlin (DRUG).
Who is sponsoring clinical trial NCT02545283?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02545283's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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