Graft vs Host Disease
Conditions
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.
Interventions
DRUGTacrolimus
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)
DRUGCyclosporine
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)
DRUGMethotrexate
D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed