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To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.
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 | Drug: Busulfan 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 |
|
| 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 |
|---|---|---|
| 1-year event free survival after hematopoietic stem cell transplantation. | To evaluate 1-year event free survival after hematopoietic stem cell transplantation. | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment rate | To evaluate engraftment rate | 1, 3, 6 and 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities associated with hematopoietic stem cell transplantation | To evaluate toxicities associated with hematopoietic stem cell transplantation. Toxicities will be assessed with number of participants. | 1, 3, 6 and 12 months after transplantation |
| Acute GVHD |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, MD, PhD | Contact | 82 2 2072 3304 | kanghj@snu.ac.kr | |
| Che Ry Hong, MD | Contact | 82 2 2072 3778 | cheryhong84@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, MD, PhD | 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 |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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To evaluate acute GVHD |
| 1, 3, 6 and 12 months after transplantation |
| Chronic GVHD | To evaluate chronic GVHD | 1, 3, 6 and 12 months after transplantation |
| Treatment related mortality | To evaluate treatment related mortality | 1, 3, 6 and 12 months after transplantation |
| Relapse rate | To evaluate relapse rate | 1, 3, 6 and 12 months after transplantation |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |