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

ConditionAML, Adult
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-65
SponsorRuijin Hospital

About this trial

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

Eligibility criteria

Qualifiers

Age 16-65 years and with an ECOG physical fitness score of 0-2 and an HCT-CI of less than 3;

Diagnosis: All enrolled cases were diagnosed with acute myeloid leukemia (AML-MR) after bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal examination, and gene mutation, and achieved hematological remission (bone marrow smear primitive cells <5%) and negative MRD before transplantation.

Have a medically qualified and suitable hematopoietic stem cell donor, including HLA-allogamous sibling donors, unrelated donors (HLA high-resolution 9-10/10 compatible) or related haploidentical donors;

No dysfunction of the heart, liver, lungs, kidneys, or other important organs, as defined as follows: ALT and AST ≤3 times the upper limit of normal; total bilirubin ≤2 times the upper limit of normal); BUN and Cr ≤1.25 times the upper limit of normal; electrocardiograms not suggestive of acute myocardial infarction or serious arrhythmias; cardiac echocardiography left ventricular ejection fraction ≥50%, no significant cardiac enlargement, valvular disease, or congenital heart disease; pulmonary function examination FEV1, FVC, DLCO ≥ 60% of the predicted value.

Disqualifiers

AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions;

Active hepatitis B (HBV-DNA ≥1×10^3 copies/ml);

HIV-infected patients;

Active infections requiring intravenous antibiotic therapy;

Trial design

Treatments tested in this trial

  • Decitabine
  • Fludarabine Injection
  • Busulfan Injection

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators