NCT03250546

Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
PROCEDURE	transplant from a haplo-identical donor	The transplant procedures will be similar in the 2 groups beside the origin of cells
PROCEDURE	transplant from a non related donor	The transplant procedures will be similar in the 2 groups beside the origin of cells

Timeline

• Start date: 2017-11-20
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2017-08-15
• Last updated: 2019-02-19

Locations

2 sites across 1 country: France