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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: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absolute neutrophil count (ANC) measured 8 weeks after the addition of allopurinol (study week 9).
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 |
What the finished NCT02046694 record still lists
NCT02046694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Allopurinol is the first listed.
NCT02046694 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02046694's enrollment target sits among peer trials
34 748th of 2000 higher than 1,239 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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