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NCT06639958Suspended

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 · Last updated 5 Oct 2026

Reason given: All potential pilot phase pts have been enrolled.

Brief summary (registry, in English)

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.

Status (registry)
Suspended
Study type
Interventional
Enrollment
64 (estimated)
First submitted
10 Oct 2024
Start date
4 Dec 2024
Primary completion date
3 Mar 2027
Lead sponsor
Children's Oncology Group
NCT number
NCT06639958

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 10 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
C S Mott Children's HospitalAnn ArborUnited StatesUnknown status
Dell Children's Medical Center of Central TexasAustinUnited StatesUnknown status
Sinai Hospital of BaltimoreBaltimoreUnited StatesUnknown status
Eastern Maine Medical CenterBangorUnited StatesUnknown status
Children's Hospital of AlabamaBirminghamUnited StatesUnknown status
Roswell Park Cancer InstituteBuffaloUnited StatesUnknown status
Prisma Health Richland HospitalColumbiaUnited StatesUnknown status
Inova Fairfax HospitalFalls ChurchUnited StatesUnknown status
Golisano Children's Hospital of Southwest FloridaFort MyersUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green BayGreen BayUnited StatesUnknown status
Riley Hospital for ChildrenIndianapolisUnited StatesUnknown status
Nemours Children's Clinic-JacksonvilleJacksonvilleUnited StatesUnknown status
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas VegasUnited StatesUnknown status
University Medical Center of Southern NevadaLas VegasUnited StatesUnknown status
Sunrise Hospital and Medical CenterLas VegasUnited StatesUnknown status
Summerlin Hospital Medical CenterLas VegasUnited StatesUnknown status
Arkansas Children's HospitalLittle RockUnited StatesUnknown status
Children's Hospital of The King's DaughtersNorfolkUnited StatesUnknown status
Kaiser Permanente-OaklandOaklandUnited StatesUnknown status
Nemours Children's HospitalOrlandoUnited StatesUnknown status
AdventHealth OrlandoOrlandoUnited StatesUnknown status
Children's Hospital of PhiladelphiaPhiladelphiaUnited StatesUnknown status
Rhode Island HospitalProvidenceUnited StatesUnknown status
Renown Regional Medical CenterRenoUnited StatesUnknown status
Methodist Children's Hospital of South TexasSan AntonioUnited StatesUnknown status
Madigan Army Medical CenterTacomaUnited StatesUnknown status
Alfred I duPont Hospital for ChildrenWilmingtonUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.