Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Seoul National University Hospital
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01472055
First received: November 6, 2011
Last updated: August 18, 2014
Last verified: August 2014
  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
  1. Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min
  2. Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr
  3. Population pharmacokinetics analysis
  4. Comparative analysis of population pharmacokinetics in pediatric and adult patients
  5. Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate

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:

  1. Conditioning regimen including fludarabine
  2. Age: < 19 years old
  3. Functional class: ECOG 0-2
  4. 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.
  5. No active viral or fungal infection
  6. Appropriate hematopoietic stem cell donor
  7. Informed consent from patients' parents

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Disease progression due to clinical test
  3. Psychiatric disease may interfere with clinical test
  4. Whether attending physician consider the patient inappropriate for study enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ministry of Food and Drug Safety, Korea
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: August 18, 2014
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, Aplastic
Leukemia
Anemia
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Fludarabine phosphate
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014