Clinical trial · Observational
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
NCT01324336CI-TRIAL-00049233completedClinicalTrials.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 purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-Mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 4-17 years, receiving 6-MP
- interventionNames
- Drug: 6-Mercaptopurine
Primary outcomes (1)
- measure
- Pharmacokinetics of 6-MP
- timeFrame
- 8 hours post administration
- description
- To compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included. Exclusion Criteria: * Inability to have blood drawn for the screening lab tests * Received methotrexate or folate supplement within the last 24 hours * Pregnant or lactating females * Inability to swallow a pill * Hemoglobin less or equal to 8 gm/dl * Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator * Weight \< or = 16 kg
References
Publications (0)
Data not yet available
No reference posted for this study.