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

NCT06829472 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Phase 3

Started

2023-12-01

Last updated

2025-02-17

Condition(s) studied

ToxicitiesSurvivorship

Investigational drug(s) / intervention(s)

melphalan

melphalan: conditioning regimen with melphalan, busulfan and fludarabine

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

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

Primary outcome measure(s)

Toxicities — up to 100 days
Toxicities with grade III or over

Trial sites (2)

Facility	City	Region	Status
Rui Jin Hospital	Shanghai	Shanghai Municipality	Recruiting
Zhaxin Hospital, Go Broad Health Care	Shanghai	Shanghai Municipality	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829472 on ClinicalTrials.gov ↗ ← All trials in China