drugset
drugset / Trial / NCT01428973

Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

NCT01428973 ↗

Phase 2 Unknown 200 enrolled University of Liege AZ Delta · collabAZ Sint-Jan AV · collabCliniques Universitaires de Mont-Godinne · collabCliniques universitaires Saint-Luc- Université Catholique de Louvain · collabHospital de Jolimont · collabJules Bordet Institute · collabUniversitair Ziekenhuis Brussel · collabUniversity Hospital, Antwerp · collabUniversity Hospital, Gasthuisberg · collabUniversity Hospital, Ghent · collabZiekenhuis Netwerk Antwerpen (ZNA) · collab
RandomizedParallel-groupOpen-labelPrevention

Summary

The present project is a multicenter phase II trail aiming at comparing which of the two postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent graft-versus-host disease (GVDH). The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity conditioning with Fludarabine/total body irradiation (TBI) or Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free survival due to a lower incidence of relapse/progression.

Timeline

Start
2011-09
Primary completion
2024-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Subject Sirolimus Small molecule 1 mg Oral
Subject Sirolimus Small molecule 2 mg Oral

Indications

graft versus host disease hematopoietic and lymphoid cell neoplasm