drugset / Trial / NCT01751997

Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors

NCT01751997

Phase 2/3 Completed 116 enrolled Byung-Sik Cho
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the clinical outcomes of transplants from family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings 1. Primary objectives: Overall survival of FMT may be similar to that of MUT 2. Secondary objectives: i. Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT. ii. Investigation of possible biomarkers related with above events after transplantation

Timeline

Start
2013-01
Primary completion
2019-05-21
Completion
2019-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 1.25 mg/kg Intravenous
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Comparator Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Transplants from family-mismatched/haploidentical donors Unknown 1.25 mg/kg Intravenous
Background Methotrexate Small molecule 5 mg/m2 Intravenous
Background Tacrolimus Small molecule 0.03 mg/kg Intravenous
Background Tacrolimus Small molecule 0.12 mg/kg Intravenous