Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed

Phase 2

Conditions

Relapse Rate After Allo-HSCT

Treatments

Drug: Flu-Bu-Mel

Study type

Interventional

Funder types

Other

Identifiers

NCT04269811

RJH-Myeloid-2020

Details and patient eligibility

About

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

Full description

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

Enrollment

49 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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