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

NCT ID: NCT06829472

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-HSCT) for patents with AML and MDS. IN our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (MBF) achieved a very low relapse rate (\~6%) in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In that study, adult patients received melphalan 140mg/m2 while patients \>=60 or with high transplantation risk in terms of HCT-CI received reduced dose of melphalan (100mg/m2). Overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.In this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18\~55) with AML/MDS receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.

Conditions

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Toxicities Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBF100

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

Group Type EXPERIMENTAL

melphalan

Intervention Type DRUG

conditioning regimen with melphalan, busulfan and fludarabine

MBF140

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

Group Type ACTIVE_COMPARATOR

melphalan

Intervention Type DRUG

conditioning regimen with melphalan, busulfan and fludarabine

Interventions

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melphalan

conditioning regimen with melphalan, busulfan and fludarabine

Intervention Type DRUG

Other Intervention Names

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MBF

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with active infection (bacteria, fungal or viral)
* Patients with abnormal liver, renal and cardiac function
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Clinical Research Center

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

Deputy director, Department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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chun Wang

Role: STUDY_DIRECTOR

Go Broad Health Care

Locations

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Rui Jin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Chun Wang

Role: CONTACT

86-13386259777

Facility Contacts

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jiong HU

Role: primary

86-13764313546

Chun Wang

Role: primary

86-13386259777

Other Identifiers

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MBF-RJH-2023

Identifier Type: -

Identifier Source: org_study_id

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