Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan

NCT06829472 | Recruiting Phase 3 DMC

• 1 other identifier: MBF-RJH-2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.

Conditions

Toxicities; Survivorship

Keywords

melphalan, AML, MDS, allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Toxicities

  Toxicities with grade III or over

  up to 100 days

Secondary Outcomes (5)

• Relapse

  2 years

• Non-relapse mortality

  100 days

• Non-relapse mortality

  2 years

• disease-free survival

  2 years

• overall survival

  2 years

Study Arms (2)

MBF100

EXPERIMENTAL

Patients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine.

Drug: melphalan

MBF140

ACTIVE COMPARATOR

Patients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine.

Drug: melphalan

Interventions

melphalan DRUG

conditioning regimen with melphalan, busulfan and fludarabine

Also known as: MBF

MBF100; MBF140

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with AML in first remission
• Patients with MDS with bone marrow blast \>5% but remain less than 20% before transplantation
• Donor available: HLA matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor
• Inform consent provided

You may not qualify if:

• Patients with active infection (bacteria, fungal or viral)
• Patients with abnormal liver, renal and cardiac function

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Clinical Research Center: collaborator

Study Sites (2)

Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Melphalan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• chun Wang

  Go Broad Health Care

  STUDY DIRECTOR

Central Study Contacts

Chun Wang

CONTACT

86-13386259777; Wangchunsh@mefmail.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: Deputy director, Department of Hematology

Model Details: Treatment

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: February 17, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CN (2)