Clinical trial · Observational
Study of Clofarabine and Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation (HCT)
Population Pharmacokinetics of the Nucleoside Analogues Clofarabine and Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (alloHCT)
- 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)
Fludarabine and clofarabine are chemotherapy drugs used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of clofarabine and 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 individual factors cause changes in clofarabine and fludarabine 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's Anemia | — | UNRESOLVED | — |
| Genetic Inborn Errors of Metabolism | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hemoglobinopathies | — | UNRESOLVED | — |
| Immunodeficiencies | — | UNRESOLVED | — |
| Nonmalignant Diseases | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
| Thalassemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
| Fludarabine Injection | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Pediatric Bone Marrow Transplantation Recipients
- description
- Children undergoing alloHCT at UCSF Benioff Children's Hospital.
- interventionNames
- Drug: Clofarabine
- Drug: Fludarabine Injection
Primary outcomes (4)
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of fludarabine and clofarabine dual therapy for HCT in pediatric patients.
- timeFrame
- 2hours post start on infusion
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of fludarabine and clofarabine dual therapy for HCT in pediatric patients.
- timeFrame
- 3hours post start of infusion
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of fludarabine and clofarabine dual therapy for HCT in pediatric patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Children 0-17 years of age * Undergoing alloHCT for the treatment of malignant or nonmalignant disorder * Receiving clofarabine and fludarabine-based preparative regimen Exclusion Criteria: * Any child 7-17 years of age unwilling to provide assent
References
Publications (0)
Data not yet available