Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
NCT ID: NCT00268528
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
720 participants
OBSERVATIONAL
2005-05-30
2020-06-30
Brief Summary
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Detailed Description
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I. To determine and compare adherence to maintenance mercaptopurine (6-MP) in a cohort of children with acute lymphoblastic leukemia (ALL) from four different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and Asians) receiving maintenance/continuation chemotherapy, using the following assessments: serial red cell 6-MP metabolites (6-thioguanine \[6TGN\] and methyl thioinosine monophosphate \[TIMP\]); frequency of 6-MP dosing using an electronic pill monitoring system (Microelectromechanical Systems \[MEMS\]?); self-report of adherence to 6-MP by questionnaire.
II. To determine the impact of adherence to 6-MP (measured using 6TGN, methyl \[Me\]TIMP, MEMS? and self-report data independently) on event-free-survival (EFS) in the entire cohort, after adjusting for known predictors of disease outcome.
III. Define a critical level of adherence (measured independently by 6TGN, MeTIMP, MEMS?, self-report) that has a significant impact on EFS for the entire cohort.
IV. Describe prevalence of adherence to 6-MP by ethnicity (6TGN, MeTIMP, MEMS?, Self-report).
V. Describe behavioral and socio-demographic predictors of adherence using the questionnaire data.
VI. Describe the pill-taking practices in this cohort using the MEMS? data. VII. To evaluate the impact of adherence on ethnic/racial difference in EFS.
SECONDARY OBJECTIVES:
I. To assess the concordance among 6TGN and MeTIMP levels, electronic pill monitoring, and self-reported adherence in the ethnic/racial groups.
OUTLINE:
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 169 days. The MEMS? TrackCap? CR is mailed to the Coordinating Center at the end of study. Patients also receive methotrexate orally (PO) as indicated by their individual chemotherapy regimen.
NOTE: \*Study closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.
After completion of study, patients are followed up every 6 months for 5 years and then annually for up to 10 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health service research (electronic pill monitoring system)
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.
Compliance Monitoring
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
Laboratory Biomarker Analysis
Correlative studies
Mercaptopurine
Given PO
Methotrexate
Given PO
Questionnaire Administration
Ancillary studies
Study of Socioeconomic and Demographic Variables
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
Interventions
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Compliance Monitoring
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
Laboratory Biomarker Analysis
Correlative studies
Mercaptopurine
Given PO
Methotrexate
Given PO
Questionnaire Administration
Ancillary studies
Study of Socioeconomic and Demographic Variables
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Asian: patients of Asian ancestry, including the following: Asian Indian (subcontinent), Chinese, Japanese, Korean, Native Hawaiian, Guamanian or Chamorro, Pacific Islander, Filipino, Vietnamese, Samoan, Hmong, Cambodian, Thai, Laotian, or Other Asian races
* Caucasian: includes White or light-skinned patients of European, North African, or Middle Eastern ancestry
* Hispanic: patients of Hispanic ethnicity, including the following: Mexican, Mexican American, Chicano, Cuban, Puerto Rican, or Other Spanish/Hispanic/Latino ethnicity
* Receiving self- or parent/caregiver-administered oral anti-metabolite chemotherapy during the maintenance/continuation phase of therapy; patients are eligible if their treatment plan calls for the following doses of 6-MP and methotrexate (MTX) during the maintenance/continuation phase: 6-MP ? 75 mg/m\^2/day orally; MTX 20 mg/m\^2/week orally;\*\* (modification of 6-MP or MTX dosing based on laboratory or clinical parameters is acceptable)
* For guidance regarding if and when a patient being treated on or according to a specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1 Eligibility by Protocol Tool,? available in the study data forms packet on the COG website
* Has completed at least 24 weeks of maintenance/continuation chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance/continuation chemotherapy\*\*
* For guidance regarding if and when a patient being treated on or according to a specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1 Eligibility by Protocol Tool,? available in the study data forms packet on the COG website
* Written informed consent from the patient and/or the patient?s legally authorized guardian, obtained prior to registration and any study-related procedures, and in accordance with institutional policies approved by the United States (U.S) Department of Health and Human Services
Exclusion Criteria
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Smita Bhatia
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Mattel Children's Hospital UCLA
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Medical Center-Parnassus
San Francisco, California, United States
Harbor-University of California at Los Angeles Medical Center
Torrance, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Charleston Division
Charleston, West Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Children's Hospital
London, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Wadhwa A, Chen Y, Hageman L, Hoppmann A, Angiolillo A, Dickens DS, Neglia JP, Ravindranath Y, Ritchey AK, Termuhlen A, Wong FL, Landier W, Bhatia S. Poverty and relapse risk in children with acute lymphoblastic leukemia: a Children's Oncology Group study AALL03N1 report. Blood. 2023 Jul 20;142(3):221-229. doi: 10.1182/blood.2023019631.
Yang JJ, Landier W, Yang W, Liu C, Hageman L, Cheng C, Pei D, Chen Y, Crews KR, Kornegay N, Wong FL, Evans WE, Pui CH, Bhatia S, Relling MV. Inherited NUDT15 variant is a genetic determinant of mercaptopurine intolerance in children with acute lymphoblastic leukemia. J Clin Oncol. 2015 Apr 10;33(11):1235-42. doi: 10.1200/JCO.2014.59.4671. Epub 2015 Jan 26.
Bhatia S, Landier W, Hageman L, Kim H, Chen Y, Crews KR, Evans WE, Bostrom B, Casillas J, Dickens DS, Maloney KW, Neglia JP, Ravindranath Y, Ritchey AK, Wong FL, Relling MV. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2014 Oct 9;124(15):2345-53. doi: 10.1182/blood-2014-01-552166. Epub 2014 May 14.
Other Identifiers
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NCI-2009-00305
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000459748
Identifier Type: -
Identifier Source: secondary_id
07-462
Identifier Type: -
Identifier Source: secondary_id
AALL03N1
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AALL03N1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL03N1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL03N1
Identifier Type: -
Identifier Source: org_study_id
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