Evidence map›Paper›PMID 35413116›Full record

Trial reportBlood advances2022

Idasanutlin plus cytarabine in relapsed or refractory acute myeloid leukemia: results of the MIRROS trial.

Marina Y Konopleva, Christoph Röllig, Jamie Cavenagh, Dries Deeren, Larisa Girshova, Jürgen Krauter, Giovanni Martinelli, Pau Montesinos, Jonas A Schäfer, Oliver Ottmann and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02545283 (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), which is not on this map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02545283 phase3terminatednot on this map

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)

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2020Enrolled447ConditionsLeukemia, Myeloid, AcuteArmsCytarabine, Idasanutlin, Placebo
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 68 citations in OpenAlex.

  1. Harnessing p53 for Proximity Killing.International journal of molecular sciences · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 19 institutions in 11 countries.

Marina Y KonoplevaUniversity of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-9347-2212
Christoph RölligUniversitätsklinikum Carl Gustav Carus, Dresden, Germany.ORCID 0000-0002-3791-0548
Jamie CavenaghBarts Health National Health Service Trust Hospital, London, United Kingdom.
Dries DeerenAlgemeen Ziekenhuis Delta, Roeselare, Belgium.
Larisa GirshovaAlmazov Medical Research Centre, St. Petersburg, Russia.ORCID 0000-0002-0559-9556
Jürgen KrauterKlinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie, Braunschweig, Germany.
Giovanni MartinelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Istituto Di Ricovero e Cura a Carattere Scientifico, Meldola, Italy;
Pau MontesinosHospital Universitari i Politècnic La Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
Jonas A SchäferUniversitätsklinikum Marburg, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Immunologie, Marburg, Germany.ORCID 0000-0001-8852-1457
Oliver OttmannCardiff University, Cardiff, United Kingdom.ORCID 0000-0001-9559-1330
Mario PetriniHematology Unit Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa, Italy.ORCID 0000-0002-1017-6961
Arnaud PigneuxCentre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France.
Alessandro RambaldiUniversity of Milan and Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
Christian RecherCentre Hospitalier Universitaire de Toulouse, Toulouse, France.
Rebeca Rodriguez-VeigaHospital Universitari i Politècnic La Fe, Valencia, Spain.
David TaussigRoyal Marsden National Health Service Foundation Trust, Marsden, United Kingdom.
Norbert VeyInstitut Paoli-Calmettes, Marseille, France.ORCID 0000-0001-7027-040X
Sung-Soo YoonSeoul National University Hospital, Seoul, South Korea.ORCID 0000-0003-2591-7459
Marion OttF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Susanne MuehlbauerF. Hoffmann-La Roche, Ltd, Basel, Switzerland.ORCID 0000-0002-4541-5379
Benjamin M BeckermannF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Olivier CatalaniF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Magali GenevrayF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Kirsten MundtF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Candice JamoisF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Pierre FenauxHôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; and.
Andrew H WeiThe Alfred Hospital and Monash University, Melbourne, Australia.ORCID 0000-0002-7514-3298
Roche (Switzerland) · CHHospital Universitari i Politècnic La Fe · ESNational Health Service · GBAZ Delta · BECardiff University · GBCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Toulouse · FRDeutsche Gesellschaft für Hämatologie und Medizinische Onkologie · DEFederal Almazov North-West Medical Research Centre · RUHôpital Saint-Louis · FRInstitut Paoli-Calmettes · FRIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITKlinik und Poliklinik für Psychotherapie und Psychosomatik · DEOspedale Papa Giovanni XXIII · ITSeoul National University Hospital · KRThe Royal Melbourne Hospital · AUThe University of Texas MD Anderson Cancer Center · USUniversitätsklinikum Gießen und Marburg · DEUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The phase 3 MIRROS (MDM2 antagonist Idasanutlin in Relapsed or Refractory acute myeloid leukemia [AML] for Overall Survival) trial (NCT02545283) evaluated the efficacy and safety of the small-molecule MDM2 antagonist idasanutlin plus cytarabine in patients with relapsed/refractory (R/R) AML. Adults (n = 447) with R/R AML whose disease relapsed or was refractory after ≤2 prior induction regimens as initial treatment or following salvage chemotherapy regimen, with Eastern Cooperative Oncology Group performance status ≤2 were enrolled regardless of TP53 mutation status and randomly assigned 2:1 to idasanutlin 300 mg or placebo orally twice daily plus cytarabine 1 g/m2 IV on days 1 to 5 of 28-day cycles. At primary analysis (cutoff, November 2019), 436 patients were enrolled, including 355 in the TP53 wild-type intention-to-treat (TP53WT-ITT) population. The primary endpoint, overall survival in the TP53WT-ITT population, was not met (median, 8.3 vs 9.1 months with idasanutlin-cytarabine vs placebo-cytarabine; stratified hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.81-1.45; P = .58). The complete remission (CR) rate, a key secondary endpoint, was 20.3% vs 17.1% (odds ratio [OR], 1.23; 95% CI, 0.70-2.18). The overall response rate (ORR) was 38.8% vs 22.0% (OR, 2.25; 95% CI, 1.36-3.72). Common any-grade adverse events (≥10% incidence in any arm) were diarrhea (87.0% vs 32.9%), febrile neutropenia (52.8% vs 49.3%), and nausea (52.5% vs 31.5%). In summary, despite improved ORR, adding idasanutlin to cytarabine did not improve overall survival or CR rates in patients with R/R AML.

Indexed as

CytarabineLeukemia, Myeloid, AcuteAdultAntineoplastic Combined Chemotherapy ProtocolsHumanspara-AminobenzoatesPyrrolidinesCytarabinepara-AminobenzoatesPyrrolidinesRG7388

Identifiers

PMID35413116
PMCPMC9327534
OpenAlexW4223440591

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.