Clinical trial · Interventional
Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Compliance Monitoring | Behavioral | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Standard Follow-Up Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (intervention program and mercaptopurine)
- description
- See detailed description.
- interventionNames
- Behavioral: Behavioral Intervention
- Behavioral: Compliance Monitoring
- Other: Laboratory Biomarker Analysis
- Drug: Mercaptopurine
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care and mercaptopurine)
- description
- Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
- interventionNames
- Behavioral: Compliance Monitoring
- Other: Laboratory Biomarker Analysis
- Drug: Mercaptopurine
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBhatia S, Hageman L, Chen Y, Wong FL, McQuaid EL, Duncan C, Mascarenhas L, Freyer D, Mba N, Aristizabal P, Walterhouse D, Lew G, Kempert PH, Russell TB, McNall-Knapp RY, Jacobs S, Dang H, Raetz E, Relling MV, Landier W. Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in Children With Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2014205. doi: 10.1001/jamanetworkopen.2020.14205. PMID 32852553