Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01503632 |
|
Recruitment Status :
Active, not recruiting
First Posted : January 4, 2012
Last Update Posted : June 10, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Childhood Acute Lymphoblastic Leukemia in Remission | Behavioral: Behavioral Intervention Behavioral: Compliance Monitoring Other: Laboratory Biomarker Analysis Drug: Mercaptopurine Other: Questionnaire Administration Procedure: Standard Follow-Up Care | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 570 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL |
| Actual Study Start Date : | February 21, 2012 |
| Actual Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm I (intervention program and mercaptopurine)
See detailed description.
|
Behavioral: Behavioral Intervention
Receive intervention program
Other Names:
Behavioral: Compliance Monitoring Correlative studies Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given orally
Other Names:
Other: Questionnaire Administration Ancillary studies |
|
Active Comparator: Arm II (standard of care and mercaptopurine)
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.
|
Behavioral: Compliance Monitoring
Correlative studies Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given orally
Other Names:
Other: Questionnaire Administration Ancillary studies Procedure: Standard Follow-Up Care Receive usual standard of care |
- Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by MEMS® [ Time Frame: 4 months ]Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the generalized estimating equation (GEE) method for longitudinal normally distributed data.
- Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by red cell TGN levels [ Time Frame: 4 months ]Compared between the IP and EDU groups using logistic regression. Mercaptopurine levels will be modeled as a function of time to examine longitudinal changes to 6TGN levels between the treatment groups using the GEE method for longitudinal normally distributed data.
- Proportion of adherence patients by sociodemographic and psychosocial variables [ Time Frame: 4 months ]Evaluated analytically by logistic regression methods.
- Mediating effect of health beliefs/ knowledge on change in adherence with intervention [ Time Frame: 4 months ]Evaluated analytically by logistic regression methods.
- Impact of IP vs. EDU on risk of relapse in children with ALL [ Time Frame: Up to 10 years ]An intention-to-treat analysis will be used to compare the effectiveness of EDU and IP interventions in decreasing the risk of relapse. Cox proportional hazards regression models will be used to examine the impact of intervention on relapse. Covariates in the analysis will include clinical and sociodemographic predictors, and the intervention arm (IP vs. EDU).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503632
Show 102 study locations
| Principal Investigator: | Smita Bhatia | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01503632 |
| Obsolete Identifiers: | NCT01476852 |
| Other Study ID Numbers: |
ACCL1033 NCI-2012-00105 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S12-01789 CDR0000721559 ACCL1033 ( Other Identifier: Childrens Oncology Group ) COG-ACCL1033 ( Other Identifier: DCP ) ACCL1033 ( Other Identifier: CTEP ) R01CA174683 ( U.S. NIH Grant/Contract ) U10CA095861 ( U.S. NIH Grant/Contract ) UG1CA189955 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 4, 2012 Key Record Dates |
| Last Update Posted: | June 10, 2022 |
| Last Verified: | May 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Mercaptopurine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |