Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
NCT03609827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2021-10-04
Summary
Melphalan 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 melphalan 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 certain clinical and individual factors cause changes in melphalan 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's Anemia
- Thalassemia
- Sickle Cell Disease
Interventions
- DRUG
-
Melphalan
Sponsors & Collaborators
-
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
- 2015-09-01
- Primary Completion
- 2021-05-31
- Completion
- 2021-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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