NCT02660684

Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor

A Historically-controlled, Multi-center Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule, Prograf Injection) and Methotrexate Combination Therapy for Prevention of GVHD in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional Cyclosporine formulation.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Prograf	Injection or oral
DRUG	Methotrexate	Injection
DRUG	Cyclosporine	Injection or oral

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2016-01-21
• Last updated: 2016-03-01

Locations

3 sites across 1 country: South Korea