Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
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|ClinicalTrials.gov Identifier: NCT01274195|
Recruitment Status : Unknown
Verified November 2013 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : January 11, 2011
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Stem Cell Transplantation||Drug: Busulfan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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
- To evaluate 1-year event free survival after hematopoietic stem cell transplantation. [ Time Frame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation ]To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
- To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate. [ Time Frame: 1, 3, 6 and 12 months after transplantation ]To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274195
|Contact: Hyoung Jin Kang, MD, PhD||82 2 2072 firstname.lastname@example.org|
|Contact: Ji Won Lee, MD||82 2 2072 email@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Daehangno, Jongno-gu, Korea, Republic of|
|Contact: Hyoung Jin Kang, MD, PhD 82 2 2072 0177 firstname.lastname@example.org|
|Contact: Ji Won Lee, MD 82 2 2072 0177 email@example.com|
|Principal Investigator: Hyo Seop Ahn, MD, PhD|
|Principal Investigator:||Hyoung Jin Kang, M.D., Ph.D||Seoul National University Hospital|