Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL
N/A
21 Years
Both
Leukemia
Trial Information
Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL
OBJECTIVES:
Primary
- Determine and compare adherence to maintenance mercaptopurine using the following
assessments: serial red cell mercaptopurine metabolites (i.e., 6TGN and methylTIMP),
frequency of mercaptopurine dosing using an electronic pill monitoring system (MEMS^®),
and self-report of adherence to mercaptopurine by questionnaire in a cohort of younger
patients with acute lymphoblastic leukemia in first remission who belong to four
different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and
Asians).
- Determine the impact of adherence to mercaptopurine on event-free-survival (EFS) in the
entire cohort, after adjusting for known predictors of disease outcome.
- Define a critical level of adherence that has a significant impact on EFS for the
entire cohort.
- Describe prevalence of adherence to mercaptopurine by ethnicity.
- Describe behavioral and sociodemographic predictors of adherence.
- Describe the pill-taking practices in this cohort.
- Evaluate the impact of adherence on ethnic/racial difference in EFS.
Secondary
- Assess the concordance among 6TGN and methylTIMP levels, electronic pill monitoring,
and self-reported adherence in the ethnic/racial groups.
OUTLINE: This is a multicenter study.
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 6 months. The MEMS^® TrackCap™ CR is mailed to the study center at the end
of study. Patients also receive oral methotrexate as indicated by their individual
chemotherapy regimen.
NOTE: *Study closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.
Blood samples are collected on days 1, 29, 57, 85, 113, 141, and 169. Patient or caregiver
completes demographic questionnaire on day 29. Patient and/or caregiver completes a
self-reported adherence questionnaire on days 29, 57, 113, and 141.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age
- Disease in first remission
- Receiving self- or parent/caregiver-administered oral antimetabolite chemotherapy
during the maintenance phase of therapy
- Has completed at least two courses* of maintenance chemotherapy, and is
scheduled to receive at least two more planned courses of maintenance
chemotherapy NOTE: *A course is defined as 12 weeks/84 days of maintenance
chemotherapy.
- Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m^2/day and
oral methotrexate at 20 mg/m^2/week during the maintenance phase
- Dose modification of 6-MP or methotrexate based on laboratory or
clinical parameters is acceptable
PATIENT CHARACTERISTICS:
- Belongs to one of the four following ethnic/racial categories: African-American,
Asian, Caucasian*, or Hispanic* NOTE: Closed to accrual for Caucasian and Hispanic
patients as of 8/14/2009.
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent enrollment on another therapeutic study for ALL allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Smita Bhatia, MD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Beckman Research Institute
Authority:
Unspecified
Study ID:
CDR0000459748
NCT ID:
NCT00268528
Start Date:
May 2005
Completion Date:
Related Keywords:
- Leukemia
- childhood acute lymphoblastic leukemia in remission
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| New York Medical College | Valhalla, New York 10595 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
| Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Children's Hospital Central California | Madera, California 93638-8762 |
| Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
| Brooklyn Hospital Center | Brooklyn, New York 11201 |
| Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Covenant Children's Hospital | Lubbock, Texas 79410 |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53226 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
| Winthrop University Hospital | Mineola, New York 11501 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| Yale Cancer Center | New Haven, Connecticut 06520-8028 |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
| Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
| Blank Children's Hospital | Des Moines, Iowa 50309 |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
| Toledo Hospital | Toledo, Ohio 43606 |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| Children's Hospital and Research Center Oakland | Oakland, California 94609 |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
| Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta, Georgia 30322 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor, Maine 04401 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
| Maimonides Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
| Akron Children's Hospital | Akron, Ohio 44308-1062 |
| Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
| Dayton Children's - Dayton | Dayton, Ohio 45404-1815 |
| Tod Children's Hospital | Youngstown, Ohio 44501 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
| Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
| West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania 18017 |
| T.C. Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
| Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
| Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan 49503 |
