Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
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)
Shanghai Jiao Tong University School of Medicine
222 participants
Oct 19, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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
Interventions
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05991908