NCT01788501View on ClinicalTrials.gov

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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 1, 2017

Study Completion Date

March 1, 2017

Conditions
Graft vs Host Disease
Interventions
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

Trial Locations (3)

Unknown

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT01788501 - Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease | Biotech Hunter | Biotech Hunter