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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus/Methotrexate | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 100 post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of infection | Fever would be categorized as fever occured before engraftment and after engraftment. If microbiologically documented, pathogen would be specified. | day 100 post transplantation |
| incidence of adverse drug reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JungMi Oh, Pharm.D | Seoul National University College of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Samsung Medical Center |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
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| 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 |
|
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
| day 100 post transplantation |
| Seoul |
| South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |