NCT01788501

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

Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease in Paediatric Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
DRUG	Tacrolimus	D-1\~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20\~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to TDM (10-20ng/ml)
DRUG	Cyclosporine	D-1\~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20\~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
DRUG	Methotrexate	D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push

Timeline

• Start date: 2011-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2013-02-11
• Last updated: 2017-03-22

Locations

3 sites across 1 country: South Korea