Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

February 14, 2025 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine

Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR <10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Kunming, China, 650000
        • Recruiting
        • 920th Hospital PLA
        • Contact:
      • Shanghai, China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital, Xianmen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • 923th Hospital PLA
        • Contact:
    • Jiang Su
      • Suzhou, Jiang Su, China, 215006
        • Recruiting
        • First Affiliatied Hospital of Soochow University
        • Contact:
    • Jiangsu
      • Nanjin, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital of Nanjin Medical Unviersity
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai No10 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
  • myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation
  • patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
  • inform consent provided

Exclusion Criteria:

  • AML patients with active CNS or extramedullary diseases
  • patients with active viral, bacterial or fungal infection
  • patients with hepatitis B virus >1X103 copy/ml
  • patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
  • patients with uncontrolled mental disorders
  • patients with HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flu-Bu2-Mel140
Patients receive fludarabine, busulfan and melphalan as conditioning regimen
Drug: Fludarabine, busulfan and melphalan
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
Active Comparator: Flu-Bu4
Patients receive fludarabine and busulfan as conditioning regimen
Drug: Fludarabine and Busulfan
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: 2 year
event defined as relapse and death of any causes
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 year
event defined as death of any causes
2 year
incidence of relapse
Time Frame: 2 year
event defined as disease relapse (bone marrow or extra medullary)
2 year
non relapse mortality
Time Frame: day 100
event defined as death without disease relapse
day 100
non relapse mortality
Time Frame: 2 year
event defined as death without disease relapse
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Chun Wang, Go Broad Health Center, Zhaxin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBF-FB4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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