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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Decitabine

    Drug

    decitabine 20mg/m2 per day for consecutive 5 days

  • Fludarabine Injection

    Drug

    fludarabine 30mg/m2 per day for consecutive 5 days

  • Busulfan Injection

    Drug

    Busulfan 3.2mg/kg per day for consecutive 4 days

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Flu-Bu4Active comparator 2 interventions
Group B: Dec-Flu-Bu4Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

disease-free survival

disease progression or death as a result of any causes

Time frame
through study completion, an average of 2 year

Secondary outcomes

1

incidence of relapse rate

disease relapse

Time frame
through study completion, an average of 2 year
2

Non-recurrent mortality

death without disease progression or relapse

Time frame
through study completion, an average of 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: