NCI ID NCI-2024-08458
NCT ID NCT06639958
CTEP ID ACCL2433
Primary Purpose PREVENTION
Anatomic Sites Lymphoid Leukemia
Minimum Age 10 Years
Maximum Age 25 Years
Gender BOTH
Lead Org Children's Oncology Group
Principal Investigator Smita Bhatia
NCI Site View on ClinicalTrials.gov

A Study of Different Programs to Help ALL Patients with Taking Maintenance Medicine at Home

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. MEMS® TrackCap™ may help patients to remember to take their 6MP medication.

Eligibility

Inclusion Criterea

  • 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 Criterea

  • 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

Participating Clinics

Renown Regional Medical Center


1155 Mill Street
Reno, NV 89502
Map

702-384-0013
research@sncrf.org

University Medical Center of Southern Nevada


1800 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center


657 Town Center Drive
Las Vegas, NV 89144
Map

702-384-0013
research@sncrf.org

Sunrise Hospital and Medical Center


3186 South Maryland Parkway
Las Vegas, NV 89109
Map

702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation


One Breakthrough Way
Las Vegas, NV 89135
Map

702-384-0013
research@sncrf.org