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

NCT06639958 | Suspended DMC

• 4 other identifiers: ACCL2433NCI-2024-08458COG-ACCL2433UG1CA189955
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (4)

• Participation

  Will calculate and report the proportion of patients eligible for the study who participate and will report a corresponding 95% confidence interval.

  At baseline (by day 1 of maintenance chemotherapy)

• Refusal reasons

  A single question in a study case report form prompts refusal reason. For each available reason, will calculate and report the proportion of patients reporting that refusal reason as well as corresponding 95% confidence intervals.

  At baseline (by day 1 of maintenance chemotherapy)

• Attrition

  Will calculate and report the proportion of patients who drop out of the study prior to completion among those eligible and enrolled and will report the corresponding 95% confidence interval.

  By 60 weeks from day 1 of maintenance chemotherapy

• Completion of study measures

  Will calculate and report the proportion of patients who complete the following measures by the end of the study follow-up period: study survey submission, MEMS® TrackCap™ return, maintenance form return, and blood sample submission. Will also report the corresponding 95% confidence intervals.

  By 60 weeks from day 1 of maintenance chemotherapy

Secondary Outcomes (2)

• 6-mercaptopurine (6MP) adherence (baseline non-adherers)

  By 60 weeks from day 1 of maintenance chemotherapy

• 6MP adherence (baseline adherers)

  By 60 weeks from day 1 of maintenance chemotherapy

Study Arms (4)

Adherers arm III (EDU)

EXPERIMENTAL

Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.

Procedure: Biospecimen Collection; Other: Informational Intervention; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Behavioral: Training and Education

Adherers arm IV (pIP)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Behavioral: Compliance Monitoring; Other: Informational Intervention; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Drug: Mercaptopurine; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Behavioral: Training and Education

Non-adherers arm I (IP)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Behavioral: Compliance Monitoring; Other: Health Promotion and Education; Other: Informational Intervention; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Drug: Mercaptopurine; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Behavioral: Training and Education

Non-adherers arm II (U-iIP)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Behavioral: Compliance Monitoring; Other: Health Promotion and Education; Other: Informational Intervention; Other: Media Intervention; Other: Medical Device Usage and Evaluation; Drug: Mercaptopurine; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Behavioral: Training and Education

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Compliance Monitoring BEHAVIORAL

Receive DST

Adherers arm IV (pIP); Non-adherers arm I (IP)

Health Promotion and Education OTHER

Receive customized printed medication schedules

Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Informational Intervention OTHER

Receive Patient Supply Kit

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Media Intervention OTHER

View MIPE program videos

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Medical Device Usage and Evaluation OTHER

Use MEMS® with TrackCap™

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Mercaptopurine DRUG

Given PO

Also known as: 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785

Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Questionnaire Administration OTHER

Ancillary studies

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Telephone-Based Intervention BEHAVIORAL

Receive automated customized electronic reminders via smartphone

Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Training and Education BEHAVIORAL

Undergo training for prompting and supervising 6MP

Adherers arm III (EDU); Adherers arm IV (pIP); Non-adherers arm I (IP); Non-adherers arm II (U-iIP)

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead

Study Sites (27)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Specimen Handling; Health Promotion; Educational Status; Mercaptopurine; azathiopurine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Smita Bhatia

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (27)