Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
This study is currently recruiting participants.
Verified February 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborator:
Korea Food and Drug Administration
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01472055
First received: November 6, 2011
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Leukemia Chronic Leukemia Severe Aplastic Anemia |
Drug: Fludarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine [ Time Frame: 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
- Evaluation of therapy related toxicity, significant adverse reaction [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 46 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fludarabine
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
|
Drug: Fludarabine
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | up to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Conditioning regimen including fludarabine
- Age: < 19 years old
- Functional class: ECOG 0-2
No loss of function of major organs. Criteria may be individualized.
- Heart: shortening fraction > 30%, ejection fraction > 45%.
- Liver: total bilirubin < 2 ⅹ upper limit of normal; ALT < 3 ⅹ upper limit of normal.
- Kidney: creatinine < 2 ⅹ normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
- No active viral or fungal infection
- Appropriate hematopoietic stem cell donor
- Informed consent from patients' parents
Exclusion Criteria:
- Pregnant or breast feeding
- Disease progression due to clinical test
- Psychiatric disease may interfere with clinical test
- Whether attending physician consider the patient inappropriate for study enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472055
Contacts
| Contact: Hyoung Jin Kang, MD, PhD | +82 2 2072 0177 | kanghj@snu.ac.kr |
| Contact: Ji Won Lee, MD | +82 2 2072 3452 | agnesjw@hanmail.net |
Locations
| 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 kanghj@snu.ac.kr | |
| Contact: Ji Won Lee, MD +82 2 2072 3452 agnesjw@hanmail.net | |
| Principal Investigator: Hyoung Jin Kang, MD, PhD | |
Sponsors and Collaborators
Seoul National University Hospital
Korea Food and Drug Administration
Investigators
| Principal Investigator: | Hyoung Jin Kang, MD., PhD | Seoul National University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01472055 History of Changes |
| Other Study ID Numbers: | SNUCH-SCT-1101 |
| Study First Received: | November 6, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
Hematopoietic stem cell transplantation with fludarabine based conditioning |
Additional relevant MeSH terms:
|
Anemia Anemia, Aplastic Leukemia Chronic Disease Hematologic Diseases Bone Marrow Diseases Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes Fludarabine Fludarabine monophosphate |
Vidarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013