Purpose

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.

Category

IRB Number
20130254HU
NCT Number
NCT01503632
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Principal Investigator
Anne-Marie Langevin

Robin Tragus
(210) 567-5262
tragus@uthscsa.edu



Eligibility

Eligible Ages
Between 1 Year and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required
    • At the time of enrollment, patient must have completed at least 24 weeks of maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy
    • Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)
    • 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
    • Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
    • 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
    • Patient and parent/caregiver must speak English or Spanish
    • 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

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Condition
  • Childhood Acute Lymphoblastic Leukemia in Remission

    • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Arm II (standard of care and mercaptopurine)

    		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.
  • Other: Laboratory Biomarker Analysis

    Correlative studies

  • Other: Questionnaire Administration

    Ancillary studies

  • Behavioral: Compliance Monitoring

    Correlative studies

  • Drug: Mercaptopurine

    Given orally

    Other names:

    • 3H-Purine-6-thiol
    • 6 MP
    • 6 Thiohypoxanthine
    • 6 Thiopurine
    • 6-Mercaptopurine
    • 6-Mercaptopurine Monohydrate
    • 6-MP
    • 6-Purinethiol
    • 6-Thiopurine
    • 6-Thioxopurine

    • Procedure: Standard Follow-Up Care

      Receive usual standard of care

    • Experimental

    Arm I (intervention program and mercaptopurine)

    		See detailed description.
  • Behavioral: Behavioral Intervention

    Receive intervention program

    Other names:

    • Behavior Conditioning Therapy
    • behavior modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral

  • Other: Laboratory Biomarker Analysis

    Correlative studies

  • Other: Questionnaire Administration

    Ancillary studies

  • Behavioral: Compliance Monitoring

    Correlative studies

  • Drug: Mercaptopurine

    Given orally

    Other names:

    • 3H-Purine-6-thiol
    • 6 MP
    • 6 Thiohypoxanthine
    • 6 Thiopurine
    • 6-Mercaptopurine
    • 6-Mercaptopurine Monohydrate
    • 6-MP
    • 6-Purinethiol
    • 6-Thiopurine
    • 6-Thioxopurine