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 |
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Recruitment Status :
Completed
First Posted : December 22, 2005
Last Update Posted : February 9, 2017
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| 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 755 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: compliance monitoring
Other: study of socioeconomic and demographic variables
Drug: mercaptopurine tablet
Given orally
Other Names:
Drug: methotrexate
Given orally
Other Names:
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| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age
- Disease in first remission
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Receiving self- or parent/caregiver-administered oral antimetabolite chemotherapy during the maintenance phase of therapy
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Has completed at least two courses* of maintenance chemotherapy, and is scheduled to receive at least two more planned courses of maintenance chemotherapy
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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
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- 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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00268528 History of Changes |
| Other Study ID Numbers: |
AALL03N1 NCI-2009-00305 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000459748 ( Other Identifier: Clinical Trials.gov ) AALL03N1 ( Other Identifier: Children's Oncology Group ) COG-AALL03N1 ( Other Identifier: DCP ) AALL03N1 ( Other Identifier: CTEP ) U10CA095861 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 22, 2005 Key Record Dates |
| Last Update Posted: | February 9, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate 6-Mercaptopurine Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |