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In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan, Pharmacokinetic | Experimental | To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan | Drug | First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study |
|
| Measure | Description | Time Frame |
|---|---|---|
| To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation. | For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate survival, toxicities, engraftment rate of patients received optimal dose of busulfan. | 1, 3, 6 and 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Daehangno, Jongno-gu | 101 | South Korea |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |