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Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Primary Purpose

Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fludarabine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring Hematopoietic stem cell transplantation with fludarabine based conditioning

Eligibility Criteria

undefined - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fludarabine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
Evaluation of therapy related toxicity, significant adverse reaction

Full Information

First Posted
November 6, 2011
Last Updated
August 18, 2014
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01472055
Brief Title
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Official Title
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
Keywords
Hematopoietic stem cell transplantation with fludarabine based conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fludarabine
Arm Type
Experimental
Arm Description
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr Population pharmacokinetics analysis Comparative analysis of population pharmacokinetics in pediatric and adult patients Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Time Frame
3 years
Title
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
Time Frame
1, 3, 6 and 12 months after transplantation
Title
Evaluation of therapy related toxicity, significant adverse reaction
Time Frame
for 4 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung Jin Kang, MD, PhD
Phone
+82 2 2072 0177
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Won Lee, MD
Phone
+82 2 2072 3452
Email
agnesjw@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehangno, Jongno-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD, PhD
Phone
+82 2 2072 0177
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Won Lee, MD
Phone
+82 2 2072 3452
Email
agnesjw@hanmail.net
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

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