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Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Children's Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01503632
First received: January 3, 2012
Last updated: September 23, 2016
Last verified: September 2016
  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 in 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.

Condition Intervention Phase
Childhood Acute Lymphoblastic Leukemia in Remission
Behavioral: behavioral intervention
Drug: mercaptopurine
Procedure: standard follow-up care
Behavioral: compliance monitoring
Other: questionnaire administration
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by MEMS® [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the generalized estimating equation (GEE) method for longitudinal normally distributed data.

  • Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by red cell TGN levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the GEE method for longitudinal normally distributed data.


Secondary Outcome Measures:
  • Proportion of adherence patients by sociodemographic and psychosocial variables [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Evaluated analytically by logistic regression methods.

  • Mediating effect of health beliefs/ knowledge on change in adherence with intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Evaluated analytically by logistic regression methods.

  • Impact of IP vs. EDU on risk of relapse in children with ALL [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    An intention-to-treat analysis will be used to compare the effectiveness of EDU and IP interventions in decreasing the risk of relapse. Cox proportional hazards regression models will be used to examine the impact of intervention on relapse. Covariates in the analysis will include clinical and sociodemographic predictors, and the intervention arm (IP vs. EDU).


Estimated Enrollment: 608
Study Start Date: February 2012
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (intervention program and mercaptopurine)
See detailed description.
Behavioral: behavioral intervention
Receive intervention program
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Behavioral: compliance monitoring
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
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.
Drug: mercaptopurine
Given orally
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Procedure: standard follow-up care
Receive usual standard of care
Behavioral: compliance monitoring
Correlative studies
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the impact of interventions proposed in intervention program (IP) vs. education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure).

SECONDARY OBJECTIVES:

I. Examine the modifying effect of sociodemographic and psychosocial variables, and the mediating effect of health beliefs/ knowledge on change in adherence with intervention.

II. Determine impact of IP vs. EDU on risk of relapse of ALL.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a MEMS® medication bottle with TrackCap™ with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap™. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular phone or web-based interface. Patients and caregivers are instructed to return the MEMS® medication bottle with TrackCap™ to the clinic by day 141.

ARM II: Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I.

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually until 10 years from diagnosis.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503632

  Show 83 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia, MD, MPH Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01503632     History of Changes
Obsolete Identifiers: NCT01476852
Other Study ID Numbers: ACCL1033  NCI-2012-00105  CDR0000721559  ACCL1033  COG-ACCL1033  ACCL1033  U10CA095861 
Study First Received: January 3, 2012
Last Updated: September 23, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016