Mercaptopurine Compliance for Leukemia

Recruiting in Palo Alto (17 mi)

+108 other locations

Overseen by Smita Bhatia

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

Research Team

Smita Bhatia

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients with Acute Lymphoblastic Leukemia in first remission who've completed at least 24 weeks of maintenance chemo and will continue for another 24. They must take oral Mercaptopurine, have a caregiver to help with medication routines, be willing to use text reminders, and speak English or Spanish. It's not for those with Down syndrome or enrolled in other adherence trials.

Inclusion Criteria

Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine

Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

You have Down syndrome.

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

Treatment Details

Interventions

• Compliance Monitoring (Behavioral Intervention)
• Mercaptopurine (Anti-metabolites)

Trial Overview The study tests if a special intervention helps young leukemia patients stick to their Mercaptopurine treatment better than the usual care does. This includes monitoring compliance using caps that track when the medicine bottle is opened and sending text message reminders.

Participant Groups

Group I: Arm I (intervention program and mercaptopurine) Experimental Treatment 5 Interventions

See detailed description.

Group II: Arm II (standard of care and mercaptopurine) Active Control 5 Interventions

Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.

Mercaptopurine is already approved in Canada for the following indications:

Approved in Canada as Purinethol for:

• Acute lymphoblastic leukemia (ALL)
• Chronic myeloid leukemia (CML)
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School