Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Shanghai Jiao Tong University School of Medicine
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Updated on 19 February 2024
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Summary

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.

Details
Condition Relapse Rate After Allo-HSCT
Age 16years - 65years
Treatment Flu-Bu-Mel
Clinical Study IdentifierNCT04269811
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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