Study of Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation
NCT01316549 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67
Last updated 2021-10-04
Summary
Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.
Conditions
- Hematologic Malignancies
- Nonmalignant Diseases
- Immunodeficiencies
- Hemoglobinopathies
- Genetic Inborn Errors of Metabolism
- Fanconi Anemia
- Thalassemia
- Sickle Cell Disease
Interventions
- DRUG
-
Given as injection
Sponsors & Collaborators
-
Thrasher Research Fund
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Janel R Long-Boyle, PharmD, PhD · University of California, San Francisco
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-01
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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