Population Pharmacokinetics and Pharmacodynamics of Thiotepa and TEPA in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (HCT).

About the study

Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is
a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its
primary active metabolite, TEPA. The goal of this study is to determine what causes some
children to have different drug concentrations of thiotepa and TEPA 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 genetic factors
cause changes in thiotepa and TEPA drug levels in pediatric bone marrow transplant patients
and that high levels may cause severe side-effects.

Study point of contact

Chris Dvorak, MD
415-476-0554
[email protected]
Janel R Long-Boyle, PharmD
415-514-2746
[email protected]

Locations

1 United States site

Age

< 17 Years

Study type

Observational

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

1. be between 0 to 17 years of age;

2. meet protocol specific eligibility criteria for autologous or allogeneic HCT

3. will be receiving thiotepa as part of their conditioning regimen.

participation restrictions

– Any child 7-17 years of age unwilling to provide assent

– Parent or guardian unwilling to provide written consent

Locations

  • San Francisco, California, United States, University of California, San Francisco, 94143 [Recruiting]
Last updated 2021-09-27