Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation

RJH-Myeloid-2020

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

2020-01-15

2023-03-30

2023-06-30

Completed

Early phase I

49

Inclusion Criteria: * acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome * patients with HLA matched sibling, unrelated or Haplo-identical donor Exclusion Criteria: * patients with active infection * patients with abnormal liver function damage: ALT/AST above 2X normal range * patients with abnormal renal function damage Scr\>160µmol/L; * patients with insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%) * patients with mental instability or unwilling to give inform consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

2023-10-25