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Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

Assistance Publique - Hôpitaux de Paris · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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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.
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