Home › Trials › NCT06639958

Helping patients with acute lymphoblastic leukemia remember to take their maintenance medication at home

Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults With ALL - A Pilot Study

Not applicable Interventional Children's Oncology Group · NCT06639958

This study tests different ways to help patients with acute lymphoblastic leukemia remember to take their maintenance medication at home using a special bottle that tracks when it's opened.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment64 (estimated)
Ages10 Years to 25 Years
SexAll
SponsorChildren's Oncology Group Research network
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT06639958 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates different programs aimed at improving adherence to maintenance medication for patients with acute lymphoblastic leukemia (ALL). It utilizes a special medication bottle equipped with a TrackCap™ that records when the bottle is opened, allowing researchers to monitor medication adherence. The study includes various intervention packages designed to enhance patient engagement and adherence to the prescribed medication regimen. Data will be collected on participation rates, reasons for refusal, and the effectiveness of the interventions in improving medication adherence.

Who should consider this trial

Good fit: Ideal candidates are patients aged 10 to 25 years who are starting maintenance therapy for ALL and can use the MEMS® TrackCap™.

Not a fit: Patients who are currently participating in another intervention trial aimed at improving medication adherence may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve medication adherence among ALL patients, leading to better treatment outcomes.

How similar studies have performed: Other studies have shown success in using technology to enhance medication adherence, making this approach promising yet still innovative.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic LeukemiaChildhood Acute Lymphoblastic Leukemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.