Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease
- Conditions
- Graft vs Host Disease
- Interventions
- Registration Number
- NCT01788501
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Evidence of HIV infection
- Documented uncontrolled disease (infections)
- Prior transplantation (hematopoietic stem cell or solid organs)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus/Methotrexate Tacrolimus 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 Cyclosporine/Methotrexate 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 Tacrolimus/Methotrexate 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 Cyclosporine/Methotrexate Cyclosporine 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
- Primary Outcome Measures
Name Time Method incidence of grade II-IV acute graft versus host disease 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 Outcome Measures
Name Time Method incidence of infection day 100 post transplantation Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified.
incidence of adverse drug reactions 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
Trial Locations
- Locations (3)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of