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NCT01503632 · ClinicalTrials.gov registry record · Phase 3
Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
A Phase 3 study of Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 570
- Enrollment target
- 20
- Study locations
NCT01503632: Active Phase 3 study of Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
NCT01503632 is a Phase 3 study of Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 570 participants, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01503632, a Phase 3 study of Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 570 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
Primary Outcome
Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the generalized estimating equation (GEE) method for longitudinal normally distributed data.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- BEHAVIORAL Behavioral Intervention
- DRUG Mercaptopurine
- BEHAVIORAL Compliance Monitoring
Study Locations (20)
Florida
- Lee Memorial Health System - Fort Myers
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- University of Florida Health Science Center - Gainesville - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Nemours Children's Clinic - Orlando - Orlando
- Nemours Children's Hospital - Orlando
- Nemours Children's Clinic - Pensacola - Pensacola
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
What the registry record for NCT01503632 still lists
NCT01503632 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (51% higher).
The record links to 1 condition, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01503632 names 20 study sites across 6 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01503632 about?
NCT01503632 is a clinical study titled "Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission". This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients wh...
What is the current status of trial NCT01503632?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 570 participants. The study started on 2012-02-21. Estimated completion is 2029-12-31.
What conditions does trial NCT01503632 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT01503632?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Behavioral Intervention (BEHAVIORAL), Mercaptopurine (DRUG), Compliance Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT01503632?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01503632 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01503632's enrollment target sits among peer trials
570 12th of 131 higher than 120 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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.
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