Know Cancer

forgot password

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Phase 2
19 Years
Open (Enrolling)
Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia

Thank you

Trial Information

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

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).

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Hyoung Jin Kang, MD., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

September 2014

Related Keywords:

  • Acute Leukemia
  • Chronic Leukemia
  • Severe Aplastic Anemia
  • Hematopoietic stem cell transplantation with fludarabine based conditioning
  • Anemia
  • Anemia, Aplastic
  • Leukemia
  • Chronic Disease