drugset / Trial / NCT06297772

Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR

NCT06297772

Phase 3 Not yet recruiting 220 enrolled Ruijin Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities

Timeline

Start
2024-06-01
Primary completion
2026-03-01
Completion
2028-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2
Background Busulfan Small molecule 3.2 mg/kg
Background Fludarabine Small molecule 30 mg/m2