Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01472055|
Recruitment Status : Unknown
Verified August 2014 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : November 16, 2011
Last Update Posted : August 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia Chronic Leukemia Severe Aplastic Anemia||Drug: Fludarabine||Phase 2|
Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.
Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.
Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).
|Study Type :||Interventional|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients [ Time Frame: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose ]
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients [ Time Frame: 3 years ]
- Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine [ Time Frame: 1, 3, 6 and 12 months after transplantation ]
- Evaluation of therapy related toxicity, significant adverse reaction [ Time Frame: for 4 weeks ]
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): NCT01472055
|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 3452 email@example.com|
|Principal Investigator: Hyoung Jin Kang, MD, PhD|
|Principal Investigator:||Hyoung Jin Kang, MD., PhD||Seoul National University Hospital|