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NCT02046694 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
NCT02046694 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 34 participants.
The verdict
NCT02046694, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This research is being done to determine if allopurinol can change the metabolism of the oral chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses need to be increased in order to get the ANC into a specific target range. Also, increasing the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea, and abdominal discomfort. Previous studies in children with inflammatory bowel disease has shown that combining allopurinol with 6-MP can decrease side effects associated with high doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research study, the investigators hope to show that the combination of allopurinol and 6-MP will be safe, tolerable, and effective in children with ALL.
Interventions
- DRUG Allopurinol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-01-06 |
| Est. Completion | 2020-04-06 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046694
The ClinicalTrials.gov registry entry for NCT02046694 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Allopurinol is the first listed.
NCT02046694 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02046694 about?
NCT02046694 is a clinical study titled "A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL". This research is being done to determine if allopurinol can change the metabolism of the oral chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the dose is adjusted accordin...
What is the current status of trial NCT02046694?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2014-01-06. Estimated completion is 2020-04-06.
What interventions are being tested in trial NCT02046694?
The interventions under investigation include: Allopurinol (DRUG).
Who is sponsoring clinical trial NCT02046694?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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