Compares two chemotherapy preparations before stem cell transplant in adult leukemia
Tests adding decitabine to fludarabine and busulfan before transplant in adults with leukemia.
Plain-language title generated from the registry record
Registry title: Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 16 to 65 with acute myeloid leukemia with myelodysplasia-related changes (AML-MR) who are in remission and about to have a stem cell transplant from a donor.
- Age
- 16 to 65 years
- Sex
- All sexes
- Disease stage
- Acute myeloid leukemia (AML-MR) in blood remission (bone marrow primitive cells under 5%) with no measurable residual disease (MRD negative) before the transplant.
- Biomarker or test result
- AML-MR diagnosis confirmed by bone marrow tests, chromosome tests and gene mutation tests.
Main reasons for not taking part
- Leukemia not in remission, or leukemia in the brain and spinal cord (CNS) or outside the bone marrow
- Active hepatitis B
- HIV infection
- Active infection that needs antibiotics through a vein
- Serious failure of the heart, lungs, liver or kidneys
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 65 years old?
Source: NCT06297772, who can take part
Where in China
- Ruijin hospitalShanghai, ChinaContact: Xiaoxia HuNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06297772
- Record updated
- 4 June 2024
- Original description
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 abnormalitiesRead full original descriptionShow less
Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as Conditioning Regimens for AML-MR
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
Inclusion: 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; The patient and his/her legal representative have the desire and requirement to undergo hematopoietic stem cell transplantation and sign an informed consent, willingness and compliance with the treatment plan, follow-up schedule, laboratory tests, etc.
Exclusion: AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions; Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results; HIV-infected patients; Active infections requiring intravenous antibiotic therapy; There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc; Active hepatitis B (HBV-DNA ≥1×10\^3 copies/ml); Mentally challenged/unable to obtain informed consent; Those judged by the investigator to be unsuitable for participation in this trial.