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

Recruiting in Palo Alto (17 mi)

+134 other locations

Overseen bySmita Bhatia

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission. 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.

Research Team

Smita Bhatia

Principal Investigator

Children's Oncology Group

Eligibility Criteria

Inclusion Criteria

Diagnosis of ALL in first remission, irrespective of risk stratification; enrollment on a Children's Oncology Group (COG) therapeutic study for ALL is not required, but the treatment plan must meet the criteria in this protocol

Belongs to one of the four following ethnic/racial categories: African-American, Asian, Caucasian, or Hispanic; below please find definitions for these categories

African-American: includes patients who are African-American or of sub-Saharan black African ancestry

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Treatment Details

Interventions

Compliance Monitoring (Behavioural Intervention)
Mercaptopurine (Anti-metabolites)
Methotrexate (Anti-metabolites)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Health service research (electronic pill monitoring system)Experimental Treatment6 Interventions

Patients receive an electronic pill monitoring system comprising an empty MEMS\^? medication bottle with TrackCap? 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 169 days. The MEMS\^? TrackCap? CR is mailed to the Coordinating Center at the end of study. Patients also receive methotrexate PO as indicated by their individual chemotherapy regimen.

Mercaptopurine is already approved in Canada for the following indications: