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Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

RECRUITINGPhase 3Sponsored by Shanghai Jiao Tong University School of Medicine
Actively Recruiting
PhasePhase 3
SponsorShanghai Jiao Tong University School of Medicine
Started2023-10-19
Est. completion2025-10-30
Eligibility
Age16 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05991908

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

Age: 16 Years – 55 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* AML patients with active CNS or extramedullary diseases
* patients with active viral, bacterial or fungal infection
* patients with hepatitis B virus \>1X103 copy/ml
* patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
* patients with uncontrolled mental disorders
* patients with HIV

Conditions3

Acute Myeloid LeukemiaCancerMyelodysplastic Syndromes

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