Status:
ACTIVE_NOT_RECRUITING
Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE3
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the impact of interventions proposed in intervention program (IP) versus (vs.) education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute ...
Eligibility Criteria
Inclusion
- Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required
- At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy
- Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)
- Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
- Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
- Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
- Patient and parent/caregiver must speak English or Spanish
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion
- Patients with Down syndrome
- Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
Key Trial Info
Start Date :
February 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2029
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT01503632
Start Date
February 21 2012
End Date
December 31 2029
Last Update
September 22 2025
Active Locations (102)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010