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Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Recruiting
16-65 years
All
Phase 2

Overview

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

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.

Eligibility

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>160mol/L;
  • patients with insufficient pulmonary function (FEV1FVCDLCO<50%and heart failure or with EF <50%)
  • patients with mental instability or unwilling to give inform consent

Study details
    Relapse Rate After Allo-HSCT

NCT04269811

Shanghai Jiao Tong University School of Medicine

16 February 2024

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