Clinical Research Directory
Browse clinical research sites, groups, and studies.
Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Phase III comparative, open-label, randomized (1:1) trial designed to evaluate the efficacy of reducing the total dose of PTCy to 70 mg/kg on GREFS compared to the standard dose of 100 mg/kg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.
Official title: Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-09
Completion Date
2029-09
Last Updated
2025-09-25
Healthy Volunteers
No
Interventions
Cyclophosphamide 35mg/kg/day
Cyclophosphamide will be administered intravenously (IV) post-HSCT at the experimental dose (70 mg/kg, divided into two doses of 35 mg/kg/day on days +3 and +4).
Cyclophosphamide 50mg/kg/day
Cyclophosphamide will be administered intravenously (IV) post-HSCT at the standard dose (100 mg/kg, divided into two doses of 50 mg/kg/day on days +3 and +4).
Locations (1)
Saint Antoine Hospital - Hematology Department
Paris, France