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Completed

NCT Number: NCT01788501

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

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.

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Key information

Conditions

Graft vs Host Disease Immune System Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tacrolimus

Drug

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)

cyclosporine

Drug

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

Drug

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

Primary outcomes

  1. incidence of grade II-IV acute graft versus host disease

    Time frame: day 100 post transplantation

    Overall grade I graft-versus-host disease denoted stage 1 to 2 skin involvement with no liver or gut involvement. Overall grade II graft-versus-host disease denoted stage 3 skin involvement or stage 1 liver or gut involvement. Overall grade III graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement without graft-versus-host disease as a major contributing cause of death. And Overall grade IV graft-versus-host disease denoted stage 4 skin involvement or stage 2 to 4 liver or gut involvement with graft-versus-host disease as a major contributing cause of death.

Secondary outcomes

  1. incidence of infection

    Time frame: day 100 post transplantation

    Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.

  2. incidence of adverse drug reactions

    Time frame: day 100 post transplantation

    adverse drug reactions would be measured by Common Terminology Criteria for Adverse Events v3. And for determinating the likelihood of whether an adverse drug reaction is actually due to the drug, Naranjo algorithm would be used

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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