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

Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06829472

Enrollment

120

Registered

2025-02-17

Start date

2023-12-01

Completion date

2026-12-01

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survivorship, Toxicities

Keywords

melphalan, AML, MDS, allogeneic stem cell transplantation

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.

Detailed description

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.

Interventions

DRUGmelphalan

conditioning regimen with melphalan, busulfan and fludarabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Treatment

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Toxicities	up to 100 days	Toxicities with grade III or over

Secondary

Measure	Time frame	Description
Relapse	2 years	Documentation of bone marrow blasts \>5% or extra medullary disease
Non-relapse mortality	100 days	Death without documentation of AML and MDS disease
disease-free survival	2 years	event defined as documentation of AML and MDS relapse or death of any causes
overall survival	2 years	event defined as death of any causes

Countries

China

Contacts

Primary ContactChun Wang

Wangchunsh@mefmail.com.cn86-13386259777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026