Clinical trial · Observational
Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Population Pharmacokinetics (PK) of Melphalan in Pediatric Patients Undergoing Allogeneic 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)
Melphalan 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 melphalan 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 individual factors cause changes in melphalan 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Pediatric patients undergoing Hematopoietic Stem Cell Transplant
- description
- Children undergoing allogeneic hematopoietic stem cell transplant (alloHCT) at University of California, San Francisco Benioff Children's Hospital.
- interventionNames
- Drug: Melphalan
Primary outcomes (5)
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of melphalan for HCT in pediatric patients.
- timeFrame
- 5min post end of infusion
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of melphalan for HCT in pediatric patients.
- timeFrame
- 15 min post end of infusion
- measure
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of melphalan 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 melphalan-based preparative regimen Exclusion Criteria: * Any child 7-17 years of age unwilling to provide assent
References
Publications (0)
Data not yet available