Status:
COMPLETED
Flu-Bu-Mel Conditioning Regimen for Myeloid Disease
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Relapse Rate After Allo-HSCT
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
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) + me...
Eligibility Criteria
Inclusion
- acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
- patients with HLA matched sibling, unrelated or Haplo-identical donor
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04269811
Start Date
January 15 2020
End Date
June 30 2023
Last Update
October 25 2023
Active Locations (2)
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1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, China, 200025
2
Shanghai No6 Hospital
Shanghai, China