Clinical trial · Observational
Study of Thiotepa and TEPA Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Population Pharmacokinetics and Pharmacodynamics of Thiotepa and TEPA in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (HCT).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fanconi Anemia | — | UNRESOLVED | — |
| Genetic Inborn Errors of Metabolism | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hemoglobinopathies | — | UNRESOLVED | — |
| Immune Deficiency | — | UNRESOLVED | — |
| Nonmalignant Diseases | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
| Thalassemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Pediatric Hematopoietic Stem Cell Transplant Recipients
- description
- Children undergoing hematopoietic stem cell transplant (HCT) at University of California, San Francisco Benioff Children's Hospital
- interventionNames
- Drug: Thiotepa
Primary outcomes (4)
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of thiotepa for HCT in pediatric patients.
- timeFrame
- 2 hours post start of infusion
- description
- Area-under-the-curve (AUC) will be derived from the empirical Bayes estimates of individual clearance
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of thiotepa for HCT in pediatric patients.
- timeFrame
- 4 hours post start of infusion
- description
- Area-under-the-curve (AUC) will be derived from the empirical Bayes estimates of individual clearance
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
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. Exclusion Criteria: * Any child 7-17 years of age unwilling to provide assent * Parent or guardian unwilling to provide written consent
References
Publications (0)
Data not yet available