Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\ 20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 55
Healthy Volunteers: f
View:

• acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission

• myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation

• patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors

• inform consent provided

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
920th Hospital PLA
RECRUITING
Kunming
First Affiliated Hospital of Nanjin Medical Unviersity
RECRUITING
Nanjin
923th Hospital PLA
RECRUITING
Nanning
Ruijin Hospital
RECRUITING
Shanghai
Shanghai No 6 Hospital
RECRUITING
Shanghai
Shanghai No10 Hospital
RECRUITING
Shanghai
First Affiliatied Hospital of Soochow University
RECRUITING
Suzhou
Zhongshan Hospital, Xianmen University
RECRUITING
Xiamen
Contact Information
Primary
chun Wang
wangchunsh@126.com
13386259777
Time Frame
Start Date: 2023-10-19
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 222
Treatments
Experimental: Flu-Bu2-Mel140
Patients receive fludarabine, busulfan and melphalan as conditioning regimen
Active_comparator: Flu-Bu4
Patients receive fludarabine and busulfan as conditioning regimen
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

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