Study to Assess Compliance With Long-Term MercaptopurineTreatment in Young Patients With Acute Lymphoblastic Leukemia in Remission - Tabular View

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Tracking Information

First Received Date ^†

December 20, 2005

Last Updated Date

May 9, 2009

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00268528 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL

Brief Summary

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.

Detailed Description

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Leukemia

Intervention ^†

Behavioral: compliance monitoring
Drug: mercaptopurine
Drug: methotrexate
Other: study of socioeconomic and demographic variables

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

720

Completion Date

Estimated Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility 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/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

PATIENT CHARACTERISTICS:

Belongs to one of the four following ethnic/racial categories: African-American, Asian, Caucasian, or Hispanic

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent enrollment on another therapeutic study for ALL allowed

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268528

Responsible Party

Secondary IDs ^††

COG-AALL03N1

Study Sponsor ^†

Children's Oncology Group

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:	Smita Bhatia, MD	Beckman Research Institute
Investigator:	Mary Relling, PharmD	St. Jude Children's Research Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.