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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Rui Jin Hospital
RECRUITING
Shanghai
Zhaxin Hospital, Go Broad Health Care
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Chun Wang
Wangchunsh@mefmail.com.cn
86-13386259777
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 120
Treatments
Experimental: MBF100
Patients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine.
Active_comparator: MBF140
Patients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Clinical Research Center
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

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