View Clinical Trial (Medical Research Study)
Population Pharmacokinetics of Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94143 |
| Conditions: |
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Hematologic Malignancies - Nonmalignant Diseases - Immunodeficiencies - Hemoglobinopathies - Genetic Inborn Errors of Metabolism - Fanconi's Anemia, - Thalassemia - Sickle Cell Disease |
| Purpose: |
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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.
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| Study Summary: |
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Fludarabine is a nucleoside analog with potent antitumor and immunosuppressive properties
used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation
(alloHCT) to promote stem cell engraftment.
This is a single-center, pharmacokinetic-pharmacodynamic (PK-PD) study investigating the
clinical pharmacology of fludarabine in 45 children undergoing alloHCT at UCSF Benioff
Children's Hospital.
Patients would receive fludarabine regardless of whether or not they decide to consent to PK
sampling.
Fludarabine doses will not be adjusted based on PK data.
We will apply the combination of a D-optimality-based limited sampling strategy and
population PK methodologies to determine specific factors influencing fludarabine exposure
in pediatric alloHCT recipients and identify exposure-response relationships.
Subjects will undergo PK sampling of plasma (f-ara-a) and intracellular (f-ara-ATP) drug
concentrations over the duration of fludarabine therapy (3 to 5 days).
To evaluate sources of variability impacting fludarabine exposure clinical data will be
obtained from the patient's medical chart on each day of PK sampling.
A single blood draw for the collection of DNA and genotyping of single nucleotide
polymorphisms of genes involved in fludarabine activation, transport or elimination will
occur in all patients.
To assess exposure-response relationships neutrophil engraftment, treatment-related
toxicity, and survival data will be collected through day 100 post-transplant.
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| Criteria: |
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Inclusion Criteria:
- Children 0-17 years of age
- Undergoing alloHCT for the treatment of malignant or nonmalignant disorder
- Receiving fludarabine-based preparative regimen
Exclusion Criteria:
- Any child 7-17 years of age unwilling to provide assent
- Parent or guardian unwilling to provide written consent
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| NCT ID: |
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NCT01316549 |
| Primary Contact: |
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Principal Investigator
Janel R Long-Boyle, PharmD, PhD
University of California, San Francisco
Janel R Long-Boyle, PharmD, PhD
Phone: 415-514-2746
Email: long-boylej@pharmacy.ucsf.edu
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| Backup Contact: |
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Email: dvorakc@peds.ucsf.edu
Chris Dvorak, MD
Phone: 415-476-0554
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| Location Contact: |
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San Francisco, California 94143
United States
Janel R Long-Boyle, PharmD, PhD
Phone: 415-514-2746
Email: long-boylej@pharmacy.ucsf.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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