Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
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|ClinicalTrials.gov Identifier: NCT00268528|
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Childhood Acute Lymphoblastic Leukemia in Remission||Behavioral: compliance monitoring Other: study of socioeconomic and demographic variables Drug: mercaptopurine tablet Drug: methotrexate||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||755 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||March 5, 2012|
|Actual Study Completion Date :||March 5, 2012|
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.
Behavioral: compliance monitoring
Other: study of socioeconomic and demographic variables
Drug: mercaptopurine tablet
Other Names:Drug: methotrexate
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268528
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|Principal Investigator:||Smita Bhatia||Children's Oncology Group|