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Clinical trial · no report yet · Phase 3

MIRROS

A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
X threads3

The trial

ClinicalTrials.gov
Official title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Phase
Phase 3
Status
Terminated
Conditions
Leukemia, Myeloid, Acute
Interventions
Cytarabine; Idasanutlin; Placebo
Arms
  • Idasanutlin plus Cytarabine · Experimental
  • Placebo plus Cytarabine · Placebo comparator
Enrollment
447
Primary outcomes
  • Overall Survival in TP53 WT Population
Sponsor
Hoffmann-La Roche
Start
Dec 30, 2015
Primary completion
Apr 24, 2020
Results posted
Yes
Registry record
NCT02545283 · updated Jan 11, 2022

Publications

linked from the registry
  • Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Recher C, Rodriguez-Veiga R, Rollig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine +/- idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13. PubMed 32167393