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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Graft vs Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tacrolimus/Methotrexate

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

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type 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)

Methotrexate

Intervention Type DRUG

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

Cyclosporine/Methotrexate

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

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type 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

Intervention Type DRUG

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

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

Eligibility Criteria

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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