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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01472055
Other study ID # SNUCH-SCT-1101
Secondary ID
Status Recruiting
Phase Phase 2
First received November 6, 2011
Last updated August 18, 2014
Start date October 2011
Est. completion date September 2014

Study information

Verified date August 2014
Source Seoul National University Hospital
Contact Hyoung Jin Kang, MD, PhD
Phone +82 2 2072 0177
Email kanghj@snu.ac.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 19 Years
Eligibility 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 ? upper limit of normal; ALT < 3 ? upper limit of normal.

- Kidney: creatinine < 2 ? 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Fludarabine
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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Daehangno, Jongno-gu

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose Yes
Secondary Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients 3 years No
Secondary Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine 1, 3, 6 and 12 months after transplantation No
Secondary Evaluation of therapy related toxicity, significant adverse reaction for 4 weeks No
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