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Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant — ALTERGREF  

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:
Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplant
Clinical Trial Details
NCT number NCT03250546
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Recruiting
Phase Phase 2
Start date November 20, 2017
Completion date November 30, 2022
View Details
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