Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

August 18, 2014 updated by: Seoul National University Hospital
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Daehangno, Jongno-gu
      • Seoul, Daehangno, Jongno-gu, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hyoung Jin Kang, MD, PhD
          • Phone Number: +82 2 2072 0177
          • Email: kanghj@snu.ac.kr
        • Contact:
        • Principal Investigator:
          • Hyoung Jin Kang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Time Frame: 3 years
3 years
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
Time Frame: 1, 3, 6 and 12 months after transplantation
1, 3, 6 and 12 months after transplantation
Evaluation of therapy related toxicity, significant adverse reaction
Time Frame: for 4 weeks
for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

  • Principal Investigator: Hyoung Jin Kang, MD., PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

November 6, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUCH-SCT-1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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