Clinical trial · Observational
Vincristine PK and PD in the AYA Population Compared to Younger Children
The Pharmacokinetics and Pharmacodynamics of Vincristine in the Adolescent and Young Adult Population Compared to Younger Children
NCT02360930CI-TRIAL-00018327unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The trial is to determine if a difference exists in the way that adolescents and young adults metabolize the chemotherapy agent vincristine compared to younger children.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Acute Lymphoblastic | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Tanner Stage </=2
- description
- Patients will be stratified by phase of treatment, and they will be classified into Tanner stage ≤ 2 or ≥ 4, based on physical examination. We plan to have 15 patients in Tanner staging ≤ 2 and 15 patients in Tanner staging ≥ 4.
- label
- Tanner Stage >/= 4
- description
- Patients will be stratified by phase of treatment, and they will be classified into Tanner stage ≤ 2 or ≥ 4, based on physical examination. We plan to have 15 patients in Tanner staging ≤ 2 and 15 patients in Tanner staging ≥ 4.
Primary outcomes (1)
- measure
- Vincristine (concentration of vincristine)
- timeFrame
- 4 weeks
- description
- We will evaluate the concentration of vincristine in relations to the production of primary metabolite M1 over time. Vincristine is primary metabolized using CYP3A family of enzymes is responsible.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ages 1-24 years of age with Acute Lymphoblastic Leukemia * Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in Induction phase of therapy * Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in first remission in Maintenance phase of therapy Treatment plan for induction therapy includes vincristine given at weekly intervals. * Treatment plan for Maintenance therapy includes vincristine given at monthly intervals. Exclusion Criteria: * Patients without a central line in induction phase of therapy
References
Publications (0)
Data not yet available
No reference posted for this study.