Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Shanghai Jiao Tong University School of Medicine49 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapse Rate After Allo-HSCT

Interventions

Flu-Bu-MelDRUG

5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, China

Shanghai No6 Hospital

Shanghai, China