Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00268528
First received: December 20, 2005
Last updated: February 13, 2014
Last verified: February 2014

December 20, 2005
February 13, 2014
May 2005
January 2100   (final data collection date for primary outcome measure)
Dummy Message [ Time Frame: Dummy Message ] [ Designated as safety issue: No ]
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Not Provided
Complete list of historical versions of study NCT00268528 on ClinicalTrials.gov Archive Site
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Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia

This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission. Assessing why young patients who have acute lymphoblastic leukemia may not take their medications as prescribed may help identify ways to assist them in taking their medications more consistently and may improve long-term treatment outcomes.

PRIMARY OBJECTIVES:

I. Determine and compare adherence to maintenance mercaptopurine using the following assessments: serial red cell mercaptopurine metabolites (i.e., 6TGN and methylTIMP), frequency of mercaptopurine dosing using an electronic pill monitoring system (MEMS®), and self-report of adherence to mercaptopurine by questionnaire in a cohort of younger patients with acute lymphoblastic leukemia in first remission who belong to four different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and Asians).

II. Determine the impact of adherence to mercaptopurine on event-free-survival (EFS) in the entire cohort, after adjusting for known predictors of disease outcome.

III. Define a critical level of adherence that has a significant impact on EFS for the entire cohort.

IV. Describe prevalence of adherence to mercaptopurine by ethnicity. V. Describe behavioral and sociodemographic predictors of adherence. VI. Describe the pill-taking practices in this cohort. VII. Evaluate the impact of adherence on ethnic/racial difference in EFS.

SECONDARY OBJECTIVES:

I. Assess the concordance among 6TGN and methylTIMP levels, electronic pill monitoring, and self-reported adherence in the ethnic/racial groups.

OUTLINE: This is a multicenter study.

Patients receive an electronic pill monitoring system comprising an empty MEMS® medication bottle with TrackCap™ child resistant (CR). The mercaptopurine prescription is filled using this system. Beginning on day 1 of the third or later course of maintenance therapy, patients take all doses of mercaptopurine from the MEMS® medication bottle with TrackCap™ CR for at least 6 months. The MEMS® TrackCap™ CR is mailed to the study center at the end of study. Patients also receive oral methotrexate as indicated by their individual chemotherapy regimen.

NOTE: *Study closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.

Blood samples are collected on days 1, 29, 57, 85, 113, 141, and 169. Patient or caregiver completes demographic questionnaire on day 29. Patient and/or caregiver completes a self-reported adherence questionnaire on days 29, 57, 113, and 141.

After completion of study treatment, patients are followed periodically.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Acute Lymphoblastic Leukemia in Remission
  • Behavioral: compliance monitoring
  • Other: study of socioeconomic and demographic variables
  • Drug: mercaptopurine tablet
    Given orally
    Other Names:
    • 6-mercaptopurine
    • 6-MP
    • Leukerin
    • MP
  • Drug: methotrexate
    Given orally
    Other Names:
    • amethopterin
    • Folex
    • methylaminopterin
    • Mexate
    • MTX
Experimental: Arm I
Patients receive an electronic pill monitoring system comprising an empty MEMS^® medication bottle with TrackCap™ child resistant (CR). The mercaptopurine prescription is filled using this system. Beginning on day 1 of the third or later course of maintenance therapy, patients take all doses of mercaptopurine from the MEMS^® medication bottle with TrackCap™ CR for at least 6 months. The MEMS^® TrackCap™ CR is mailed to the study center at the end of study. Patients also receive oral methotrexate as indicated by their individual chemotherapy regimen.
Interventions:
  • Behavioral: compliance monitoring
  • Other: study of socioeconomic and demographic variables
  • Drug: mercaptopurine tablet
  • Drug: methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
720
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age

    • Disease in first remission
  • Receiving self- or parent/caregiver-administered oral antimetabolite chemotherapy during the maintenance phase of therapy

    • Has completed at least two courses* of maintenance chemotherapy, and is scheduled to receive at least two more planned courses of maintenance chemotherapy

      • Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m^2/day and oral methotrexate at 20 mg/m^2/week during the maintenance phase

        • Dose modification of 6-MP or methotrexate based on laboratory or clinical parameters is acceptable
  • Belongs to one of the four following ethnic/racial categories: African-American, Asian,Caucasian*, or Hispanic*
  • Concurrent enrollment on another therapeutic study for ALL allowed
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Australia
 
NCT00268528
AALL03N1, NCI-2009-00305, CDR0000459748, AALL03N1, COG-AALL03N1, AALL03N1, U10CA095861
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Smita Bhatia Children's Oncology Group
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP