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

RECRUITINGPhase 3Sponsored by Shanghai Jiao Tong University School of Medicine
Actively Recruiting
PhasePhase 3
SponsorShanghai Jiao Tong University School of Medicine
Started2023-12-01
Est. completion2026-07-01
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06829472

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

Age: 18 Years – 55 YearsHealthy volunteers accepted
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

Conditions3

CancerSurvivorshipToxicities

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