Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Acute Leukemia Clinical Trial

Official title:

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01472055
• Other study ID #: SNUCH-SCT-1101
• 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

Related Conditions & MeSH terms

• Acute Leukemia
• Anemia, Aplastic
• Chronic Leukemia
• Leukemia
• Severe Aplastic Anemia

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