MedTrace Logo

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

NCT06297772 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-06-04

No results posted yet for this study

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

Conditions

  • AML, Adult

Interventions

DRUG

Decitabine

decitabine 20mg/m2 per day for consecutive 5 days

DRUG

Fludarabine Injection

fludarabine 30mg/m2 per day for consecutive 5 days

DRUG

Busulfan Injection

Busulfan 3.2mg/kg per day for consecutive 4 days

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Xiaoxia Hu · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297772 on ClinicalTrials.gov