Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Related Information
Registry Information
Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission (Closed to Accrual for Caucasian and Hispanic Patients as of 8/14/2009)
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Treatment | Closed | 21 and under at diagnosis | NCI | COG-AALL03N1 NCT00268528 |
Special Category: NCI Web site featured trial
Objectives
Primary
- 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).
- Determine the impact of adherence to mercaptopurine on event-free-survival (EFS) in the entire cohort, after adjusting for known predictors of disease outcome.
- Define a critical level of adherence that has a significant impact on EFS for the entire cohort.
- Describe prevalence of adherence to mercaptopurine by ethnicity.
- Describe behavioral and sociodemographic predictors of adherence.
- Describe the pill-taking practices in this cohort.
- Evaluate the impact of adherence on ethnic/racial difference in EFS.
Secondary
- Assess the concordance among 6TGN and methylTIMP levels, electronic pill monitoring, and self-reported adherence in the ethnic/racial groups.
Entry Criteria
Disease Characteristics:
- 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
[Note: *A course is defined as 12 weeks/84 days of maintenance chemotherapy.]
- Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m2/day and oral methotrexate at 20 mg/m2/week during the maintenance phase
- Dose modification of 6-MP or methotrexate based on laboratory or clinical parameters is acceptable
- Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m2/day and oral methotrexate at 20 mg/m2/week during the maintenance phase
- Has completed at least two courses* of maintenance chemotherapy, and is scheduled to
receive at least two more planned courses of maintenance chemotherapy
Prior/Concurrent Therapy:
- See Disease Characteristics
- Concurrent enrollment on another therapeutic study for ALL allowed
Patient Characteristics:
- Belongs to one of the four following ethnic/racial categories: African-American, Asian,
Caucasian*, or Hispanic*
[Note: Closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.]
Expected Enrollment
720A total of 720 patients will be accrued for this study.
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.
Published ResultsBhatia S, Landier W, Shangguan M, et al.: Nonadherence to Oral Mercaptopurine and Risk of Relapse in Hispanic and Non-Hispanic White Children With Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group. J Clin Oncol : , 2012.[PUBMED Abstract]
Trial Lead Organizations
Children's Oncology Group
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| Smita Bhatia, MD, MPH, Protocol chair | |
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| Mary Relling, PharmD, Protocol co-chair | |
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Related Information
| Registry Information | ||
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| Official Title | Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL | |
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| Trial Start Date | 2005-05-30 | |
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| Trial Completion Date | 2008-05-14 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00268528 | |
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| Date Submitted to PDQ | 2005-11-28 | |
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| Information Last Verified | 2011-09-10 | |
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| NCI Grant/Contract Number | CA95861 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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