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RECRUITING
NCT06829472
PHASE3

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

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-12-01

Completion Date

2026-12-01

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

DRUG

melphalan

conditioning regimen with melphalan, busulfan and fludarabine

Locations (2)

Rui Jin Hospital

Shanghai, Shanghai Municipality, China

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China