Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients

Registration Number
NCT03609840
Lead Sponsor
University of California, San Francisco
Brief Summary

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, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some children to have different drug concentrations of thiotepa and ...

Detailed Description

Thiotepa is an alkylating agent with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric hematopoietic cell transplantation (HCT) to promote stem cell engraftment. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, TEPA.
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Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
Inclusion Criteria
  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.
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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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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Pediatric Hematopoietic Stem Cell Transplant RecipientsThiotepaChildren undergoing hematopoietic stem cell transplant (HCT) at University of California, San Francisco Benioff Children's Hospital
Primary Outcome Measures
NameTimeMethod
Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of thiotepa for HCT in pediatric patients.24 hours post start of infusion

Area-under-the-curve (AUC) will be derived from the empirical Bayes estimates of individual clearance

Secondary Outcome Measures
NameTimeMethod
Event free survival according to the AUC of thiotepa1 year post transplant

Death due to any cause within day 1 year post-transplant will be considered an event.

Trial Locations

Locations (1)

University of California, San Francisco

🇺🇸

San Francisco, California, United States

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