Clinical trial · Interventional
Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR
Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as Conditioning Regimens for AML-MR
NCT06297772CI-TRIAL-00077731not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan Injection | Drug | Busulfan | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Fludarabine Injection | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Flu-Bu4
- description
- Preconditioning with Flu-Bu4 without decitabine for patients with AML-MR
- interventionNames
- Drug: Fludarabine Injection
- Drug: Busulfan Injection
- type
- EXPERIMENTAL
- label
- Dec-Flu-Bu4
- description
- Preconditioning with Flu-Bu4 and decitabine for patients with AML-MR
- interventionNames
- Drug: Decitabine
- Drug: Fludarabine Injection
- Drug: Busulfan Injection
Primary outcomes (1)
- measure
- disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.