ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : November 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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.

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

Detailed Description:

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)
Estimated Enrollment : 608 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
Estimated Primary Completion Date : March 31, 2019


Arm Intervention/treatment
Experimental: Arm I (intervention program and mercaptopurine)
See detailed description.
Behavioral: Behavioral Intervention
Receive intervention program
Other Names:
  • Behavior Conditioning Therapy
  • behavior modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • BEHAVIORAL THERAPY
  • Behavioral Treatment
  • Behavioral Treatments

Behavioral: Compliance Monitoring
Correlative studies

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Mercaptopurine
Given orally
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785

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:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785

Other: Questionnaire Administration
Ancillary studies

Procedure: Standard Follow-Up Care
Receive usual standard of care




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Proportion of adherence patients by sociodemographic and psychosocial variables [ Time Frame: 4 months ]
    Evaluated analytically by logistic regression methods.

  2. Mediating effect of health beliefs/ knowledge on change in adherence with intervention [ Time Frame: 4 months ]
    Evaluated analytically by logistic regression methods.

  3. 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).



Information from the National Library of Medicine

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
Criteria

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

Information from the National Library of Medicine

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


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, California
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Tampa General Hospital
Tampa, Florida, United States, 33606
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Saint Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
University of Illinois
Chicago, Illinois, United States, 60612
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Ascension Saint John Hospital
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Columbia University/Herbert Irving Cancer Center
New York, New York, United States, 10032
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, United States, 28801
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Mercy Children's Hospital
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Vannie Cook Children's Clinic
McAllen, Texas, United States, 78503
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
United States, Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Puerto Rico
San Jorge Children's Hospital
San Juan, Puerto Rico, 00912
University Pediatric Hospital
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01503632     History of Changes
Obsolete Identifiers: NCT01476852
Other Study ID Numbers: ACCL1033
NCI-2012-00105 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721559
S12-01789
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: November 1, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-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