Spots Global Cancer Trial Database for Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
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Trial Identification
Brief Title: Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
Official Title: Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia
Study ID: NCT00268528
Study Description
Brief Summary: 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.
Detailed Description: PRIMARY OBJECTIVES: 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, District of Columbia, United States
Children's National Medical Center, Washington, 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, Saint 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, Saint 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
Montefiore Medical Center - Moses Campus, Bronx, New York, 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
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
Contact Details
Name: Smita Bhatia
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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