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Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission

NCT01503632

CompletedPhase 3

Sponsor: Children's Oncology Group

Conditions: Acute Lymphoblastic Leukemia

Interventions: Behavioral Intervention, Compliance Monitoring, Laboratory Biomarker Analysis, Mercaptopurine, Questionnaire Administration

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 21 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Patients with Down syndrome
* Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence

Locations (102)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Downey, California, United States
Duarte, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
Hartford, Connecticut, United States
Wilmington, Delaware, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
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