Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission



Status:Active, not recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 21
Updated:11/3/2018
Start Date:February 21, 2012

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A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention
compared to standard of care in younger patients with acute lymphoblastic leukemia that has
had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing
ways to help patients who have acute lymphoblastic leukemia to take their medications as
prescribed may help them in taking their medications more consistently and may improve
treatment outcomes.

PRIMARY OBJECTIVES:

I. Determine the impact of interventions proposed in intervention program (IP) versus (vs.)
education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute
lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring
Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red
cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure).

SECONDARY OBJECTIVES:

I. Examine the modifying effect of sociodemographic and psychosocial variables, and the
mediating effect of health beliefs/ knowledge on change in adherence with intervention.

II. Determine impact of IP vs. EDU on risk of relapse of ALL.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring
system, a MEMS? medication bottle with TrackCap? with standard resistant cap, and written
instructions for the patient and pharmacist. Parents and/or caregivers are also trained to
supervise patients' intake of the medication. Beginning on day 1, patients start using the
MEMS? medication bottle with TrackCap?. Clinical research assistants contact patients and
parents by telephone the next day to confirm that TrackCap? is being used, to identify any
obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an
interactive multimedia educational program on-line or via DVD. Patients also receive a
customized electronic mercaptopurine schedule and automated customized text message reminders
delivered via cellular phone or web-based interface. Patients and caregivers are instructed
to return the MEMS? medication bottle with TrackCap? to the clinic by day 141.

ARM II: Patients receive the usual standard of care and the mercaptopurine from the MEMS?
medication bottle with TrackCap? as patients in arm I. Patients and caregivers also view an
interactive multimedia educational program on day 29.

After completion of study treatment, patients are followed up every 6 months for 5 years and
then annually until 10 years from diagnosis.

Inclusion Criteria:

- Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG)
therapeutic study for ALL is not required

- At the time of enrollment, patient must have completed at least 24 weeks of
maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of
maintenance chemotherapy

- Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held
only for toxicity or illness), and will be returning to the clinic every 4 weeks for
scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)

- Has a designated parent or caregiver who is willing to enter into a mutual agreement
with the patient to participate in a daily supervised medication administration
routine

- Able and willing to use the MEMS? TrackCap? (e.g., not using a pillbox or prescribed
liquid 6MP)

- Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular
telephone to receive medication reminders via text messaging during study period

- Patient and parent/caregiver must speak English or Spanish

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patients with Down syndrome

- Patients who previously participated in or are currently participating in another
intervention clinical trial designed to improve adherence
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2213 Cherry Street
Toledo, Ohio 43608
(419) 251-8000
Principal Investigator: Rama Jasty
Phone: 419-251-8210
Mercy Children's Hospital Mercy Children's Hospital is a regional resource for advanced pediatric care located...
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Toledo, OH
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Jeffrey S. Dome
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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901 45th St
West Palm Beach, Florida 33407
(561) 844-6300
Principal Investigator: Narayana Gowda
Phone: 888-823-5923
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
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West Palm Beach, FL
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Thomas B. Russell
Phone: 336-713-6771
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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