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In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using 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 the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan | Experimental |
|
| 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 evaluate 1-year event free survival after hematopoietic stem cell transplantation. | To evaluate 1-year event free survival after hematopoietic stem cell transplantation. | For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate. | To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate. | 1, 3, 6 and 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, MD, PhD | Contact | 82 2 2072 0177 | kanghj@snu.ac.kr | |
| Ji Won Lee, MD | Contact | 82 2 2072 0177 | agnesjw@hanmail.net |
| 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 | Recruiting | Seoul | Daehangno, Jongno-gu | 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 |