1. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia
- Author
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Rebeca Rodríguez-Veiga, Benjamin M. Beckermann, Annabelle Monnet, Olivier Catalani, Pau Montesinos, Norbert Vey, Andrew H. Wei, Sung-Soo Yoon, Cristina Papayannidis, Christoph Röllig, Katia Gamel, Giovanni Martinelli, Aaron Park, Marina Konopleva, Jordi Esteve, Pierre Fenaux, and Christian Recher
- Subjects
p53 ,Male ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Pyrrolidines ,Adolescent ,Population ,acute myeloid leukemia ,trial in progress ,Placebo ,idasanutlin ,03 medical and health sciences ,0302 clinical medicine ,AML ,MDM2 ,Refractory ,cytarabine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,para-Aminobenzoates ,medicine ,Clinical endpoint ,Humans ,IDASANUTLIN ,education ,neoplasms ,education.field_of_study ,business.industry ,Remission Induction ,Cytarabine ,Myeloid leukemia ,Proto-Oncogene Proteins c-mdm2 ,General Medicine ,Interim analysis ,MIRROS ,relapsed ,refractory ,Leukemia, Myeloid, Acute ,030104 developmental biology ,030220 oncology & carcinogenesis ,Female ,Tumor Suppressor Protein p53 ,business ,medicine.drug - Abstract
Patients with refractory or relapsed acute myeloid leukemia (R/R AML) have a poor prognosis, with a high unmet medical need. Idasanutlin is a small-molecule inhibitor of MDM2, a negative regulator of tumor suppressor p53. By preventing the p53–MDM2 interaction, idasanutlin allows for p53 activation, particularly in patients with TP53 wild-type (WT) status. MIRROS (NCT02545283) is a randomized Phase III trial evaluating idasanutlin + cytarabine versus placebo + cytarabine in R/R AML. The primary end point is overall survival in the TP53-WT population. Secondary end points include complete remission rate (cycle 1), overall remission rate (cycle 1) and event-free survival in the TP53-WT population. MIRROS has an innovative design that integrates a stringent interim analysis for futility; continuation criteria were met in mid-2017 and accrual is ongoing. Trial registration number: NCT02545283
- Published
- 2020