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ACCL2433: Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults with ALL - A Pilot Study

Primary Investigator
Goldman, Joshua
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06639958
UM Number
2025.044
Age Group
Children
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
61212
Secondary Protocol No
HUM00271837
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Lymphoid Leukemia
Summary
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.

Eligibility: 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