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

NCT06297772 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RJBMT-003
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

AML, Adult

Keywords

AML-MR; adults; conditioning regimen

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  disease progression or death as a result of any causes

  through study completion, an average of 2 year

Secondary Outcomes (2)

• incidence of relapse rate

  through study completion, an average of 2 year

• Non-recurrent mortality

  through study completion, an average of 2 year

Study Arms (2)

Flu-Bu4

ACTIVE COMPARATOR

Preconditioning with Flu-Bu4 without decitabine for patients with AML-MR

Drug: Fludarabine Injection; Drug: Busulfan Injection

Dec-Flu-Bu4

EXPERIMENTAL

Preconditioning with Flu-Bu4 and decitabine for patients with AML-MR

Drug: Decitabine; Drug: Fludarabine Injection; Drug: Busulfan Injection

Interventions

Decitabine DRUG

decitabine 20mg/m2 per day for consecutive 5 days

Dec-Flu-Bu4

Fludarabine Injection DRUG

fludarabine 30mg/m2 per day for consecutive 5 days

Dec-Flu-Bu4; Flu-Bu4

Busulfan Injection DRUG

Busulfan 3.2mg/kg per day for consecutive 4 days

Dec-Flu-Bu4; Flu-Bu4

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; fludarabine; Busulfan

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xiaoxia Hu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoxia Hu

CONTACT

+862164370045; hxx12276@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)