Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Brief Title

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Official Title

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Brief Summary

      The purpose of this study is to analysis of the pharmacokinetics of fludarabine for
      hematopoietic stem cell transplantation in pediatric patients.
    

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients

Secondary Outcome

 Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients

Condition

Acute Leukemia

Intervention

Fludarabine

Study Arms / Comparison Groups

 Fludarabine

Description:  Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

46

Start Date

October 2011

Completion Date

September 2014

Primary Completion Date

September 2014

Eligibility 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
      

Gender

All

Ages

N/A - 19 Years

Accepts Healthy Volunteers

No

Contacts

Hyoung Jin Kang, MD., PhD, +82 2 2072 0177, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT01472055

Organization ID

SNUCH-SCT-1101

Study Sponsor

Seoul National University Hospital

Collaborators

 Ministry of Food and Drug Safety, Korea

Study Sponsor

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

Verification Date

August 2014