Details

Autor(en) / Beteiligte

• Montesinos, Pau
• Beckermann, Benjamin M
• Catalani, Olivier
• Esteve, Jordi
• Gamel, Katia
• Konopleva, Marina Y
• Martinelli, Giovanni
• Monnet, Annabelle
• Papayannidis, Cristina
• Park, Aaron
• Récher, Christian
• Rodríguez-Veiga, Rebeca
• Röllig, Christoph
• Vey, Norbert
• Wei, Andrew H
• Yoon, Sung-Soo
• Fenaux, Pierre

Titel

MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia

Ist Teil von

• Future oncology (London, England), 2020-05, Vol.16 (13), p.807-815

Ort / Verlag

England: Future Medicine Ltd

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 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 -WT population. Secondary end points include complete remission rate (cycle 1), overall remission rate (cycle 1) and event-free survival in the -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. NCT02545283