Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare efficacy and safety of tacrolimus/methotrexate with cyclosporine/methotrexate for graft versus host disease prophylaxis in paediatric allogeneic hematopoietic stem cell transplantation patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Cyclosporine; Cyclosporins; Methotrexate; Tacrolimus

Criteria

Inclusion Criteria:

• Diagnosis of hematological malignancy

• Age under 18 years old

• Serum bilirubin less than 1.5 X upper limit of normal

• Aspartate transaminase, Alanine transaminase less than 2.5 X upper limit of normal

• Alkaline phosphatase less than 2.5 X upper limit of normal

• Serum creatinine less than 1.5 X upper limit of normal

• Agrees to participate, and informed consent signed

Exclusion Criteria:

• Evidence of HIV infection

• Documented uncontrolled disease (infections)

• Prior transplantation (hematopoietic stem cell or solid organs)