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

Seoul National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Graft vs Host Disease

Treatments: Drug: Cyclosporine; Drug: Methotrexate; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01788501

SNUCP_001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Tacrolimus/Methotrexate

Experimental group

Description:

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 therapeutic drug monitoring(TDM) (10-20ng/ml) Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push

Treatment:

Drug: Tacrolimus

Drug: Methotrexate

Cyclosporine/Methotrexate

Active Comparator group

Description:

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) Methotrexate D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push

Treatment:

Drug: Methotrexate

Drug: Cyclosporine