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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00268528 |
Purpose
RATIONALE: 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.
PURPOSE: This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission.
| Condition | Intervention |
|---|---|
|
Leukemia |
Behavioral: compliance monitoring Drug: mercaptopurine Drug: methotrexate Procedure: study of socioeconomic and demographic variables |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL |
| Estimated Enrollment: | 720 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age
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/m^2/day and oral methotrexate at 20 mg/m^2/week during the maintenance phase
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 128 Study Locations| Study Chair: | Smita Bhatia, MD | Beckman Research Institute |
| Investigator: | Mary Relling, PharmD | St. Jude Children's Research Hospital |
More Information
| Study ID Numbers: | CDR0000459748, COG-AALL03N1 |
| Study First Received: | December 20, 2005 |
| Last Updated: | May 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00268528 History of Changes |
| Health Authority: | Unspecified |
|
childhood acute lymphoblastic leukemia in remission |
|
Acute Lymphoblastic Leukemia, Childhood Antimetabolites Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immunologic Factors 6-Mercaptopurine Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Leukemia Lymphatic Diseases Methotrexate Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
|
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs 6-Mercaptopurine Reproductive Control Agents Leukemia Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Antirheumatic Agents Lymphoproliferative Disorders |
