The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD). It will use a Phase II, multicenter, prospective, randomized clinical trial. By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
The transplant procedures will be similar in the 2 groups beside the origin of cells
The transplant procedures will be similar in the 2 groups beside the origin of cells
Saint Louis hospital
Paris, France
RECRUITINGService Hématologie Clinique
Paris, France
RECRUITINGTwo-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
Time frame: 2 year
100 day engraftment
Time frame: day 100
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