Starting soon
Phase 3
Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR
Condition(s) studied
AML, Adult
Investigational drug(s) / intervention(s)
Decitabine: decitabine 20mg/m2 per day for consecutive 5 days
Fludarabine Injection: fludarabine 30mg/m2 per day for consecutive 5 days
Busulfan Injection: Busulfan 3.2mg/kg per day for consecutive 4 days
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
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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;
* There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc;
* Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results;
* Mentally challenged/unable to obtain informed consent;
* Those judged by the investigator to be unsuitable for participation in this trial.
Primary outcome measure(s)
- disease-free survival — through study completion, an average of 2 year
disease progression or death as a result of any causes
Trial sites (1)
| Facility | City | Region | Status |
| Ruijin Hospital |
Shanghai |
China |
|
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