Clinical trial · Interventional
A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home
Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults With ALL - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All potential pilot phase pts have been enrolled.
Summary
Brief summary (as posted)
This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.
Conditions
Conditions (2)
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 |
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Compliance Monitoring | Behavioral | — | UNRESOLVED |
| Health Promotion and Education | Other | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Media Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Adherers arm III (EDU)
- description
- Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Informational Intervention
- Other: Media Intervention
- Other: Medical Device Usage and Evaluation
- Other: Questionnaire Administration
- Behavioral: Training and Education
- type
- EXPERIMENTAL
- label
- Adherers arm IV (pIP)
- description
- See Detailed Description.
- interventionNames
- Procedure: Biospecimen Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Age: \>= 10 years and =\< 25 years * Previously enrolled onto AALL1732 * Consented to the AALL1732 mercaptopurine adherence correlative study * Maintenance therapy has not yet begun * English or Spanish-speaking (patient and parent/other adult) * Planning to receive 6MP (as tablets) during maintenance phase of therapy * Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP) * Has a designated parent/other adult who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine * Patient/parent/other adult must be willing to use a smartphone to receive medication reminders * Receiving treatment at a Children's Oncology Group (COG) institution in the United States Exclusion Criteria: * Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence * Regulatory requirements * 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
References
Publications (0)
Data not yet available