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

Seoul National University Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Graft vs Host Disease

Interventions

TacrolimusDRUG

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)

CyclosporineDRUG

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)

MethotrexateDRUG

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

incidence of grade II-IV acute graft versus host disease

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.

Time frame: day 100 post transplantation

Secondary Outcomes

incidence of infection

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

Time frame: day 100 post transplantation

incidence of adverse drug reactions

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

Time frame: day 100 post transplantation

Data from ClinicalTrials.gov

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