In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.
Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML \>=55 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai No 6 Hospital
Shanghai, China
RECRUITINGdisease-free survival
survival without disease relapse or progression
Time frame: 2 year
overall survival
survival
Time frame: 2 year
GVHD and relapse free survival
survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD.
Time frame: 2 year
Non-relapse mortality
Death without disease progression or relapse
Time frame: 2 year
Relapse
disease progression or relapse
Time frame: 2 year
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