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| Name | Class |
|---|---|
| National Institute of Food and Drug Safety Evaluation (Republic of Korea) | UNKNOWN |
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This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Cyclophosphamide | Other | Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously) Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT) |
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT) |
| Pharmacokinetics parameter of melphalan | Analysis: Area under the plasma concentration-time curve (AUC) | D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hyoung Jin Kan, MD,PhD | Contact | +82-2-2072-3304 | kanghj@snu.ac.kr | |
| Kyung Taek Hong, MD,PhD | Contact | +82-2-2072-3631 | hongkt@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, MD,PhD | l | Principal Investigator |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |