drugset / Trial / NCT05197426

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

NCT05197426 ↗

Phase 2 Active not recruiting 19 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Timeline

Start
2022-01-17
Primary completion
2025-01-27
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — Oral