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

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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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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