Relapse Rate After Allo-HSCT
Conditions
Brief 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
Detailed 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.
Interventions
DRUGFlu-Bu-Mel
5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | 1 year after transplantation | From transplantation to documentation of death or relapse or progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 1 year after transplantation | From transplantation to documentation of relapse or progression |
| non-relapse mortality (NRM) | 1 year after transplantation | From transplantation to documentation of death not due to disease relapse or progression |
| Overall survival (OS) | 1 year after transplantation | From transplantation to documentation of death due to any causes |
| chronic graft versus host disease (cGVHD) | 1 year after transplantation | Incidence of documented moderate to severe chronic GVHD |
| relapse free survival (GRFS) | 1 year after transplantation | From transplantation to documentation of death, III-IV aGVHD, moderate to severe chronic GVHD and relapse |
| acute graft versus host disease (aGVHD) | day 180 after transplantation | Incidence of documented grade II-IV acute GVHD |
Countries
China
Outcome results
None listed