drugset / Trial / NCT05020665
Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).
Timeline
- Start
- 2021-11-24
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
Outcome
Outcome not reported
Stopped (Enrollment): “Termination was due to significant challenges associated with study enrollment in a genetic subset of fit participants in the front-line acute myeloid leukemia (AML) setting and other challenges associated with post-COVID impacts.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entospletinib | Small molecule | 400 mg | Oral |
| Background | Cytarabine | Small molecule | — | — |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Idarubicin | Small molecule | — | Intravenous |