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MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia.
- Source :
- Future Oncology; May2020, Vol. 16 Issue 13, p807-815, 9p
- Publication Year :
- 2020
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 14796694
- Volume :
- 16
- Issue :
- 13
- Database :
- Complementary Index
- Journal :
- Future Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 142846065
- Full Text :
- https://doi.org/10.2217/fon-2020-0044