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

21 Years
Open (Enrolling)

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Trial Information

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



- 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

- 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.


- 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.

PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.

Inclusion Criteria


- 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

- 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


- 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.


- See Disease Characteristics

- Concurrent enrollment on another therapeutic study for ALL allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Smita Bhatia, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute



Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



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