Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00268528
First received: December 20, 2005
Last updated: April 2, 2011
Last verified: April 2011
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Purpose
RATIONALE: 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.
PURPOSE: This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission.
| Condition | Intervention |
|---|---|
|
Leukemia |
Behavioral: compliance monitoring Drug: mercaptopurine Drug: methotrexate Other: study of socioeconomic and demographic variables |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 720 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268528
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| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Southern California Permanente Medical Group | Recruiting |
| Downey, California, United States, 90027 | |
| Contact: Robert M. Cooper 323-783-5307 | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Jerry Z. Finklestein 562-728-5000 | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93638-8762 | |
| Contact: Vonda L. Crouse 559-353-5480 | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
| Palo Alto, California, United States, 95798 | |
| Contact: Neyssa M. Marina 650-723-5535 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly W. Maloney 720-777-6673 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8028 | |
| Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| University of Florida Shands Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32610-0232 | |
| Contact: Clinical Trials Office - University of Florida Shands Cancer C 888-254-7581 | |
| Memorial Cancer Institute at Memorial Regional Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Clinical Trials Office - Memorial Cancer Institute 954-985-3443 | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| Baptist-South Miami Regional Cancer Program | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Doured Daghistani 305-274-1662 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Ramamoorthy Nagasubramanian 407-650-7230 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| Nemours Children's Clinic - Pensacola | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Jeffrey H. Schwartz 850-505-4790 | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-4176 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Howard M. Katzenstein 404-785-0853 | |
| MBCCOP - Medical College of Georgia Cancer Center | Recruiting |
| Augusta, Georgia, United States, 30912-3730 | |
| Contact: Colleen H. McDonough 706-721-3626 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979 | |
| United States, Illinois | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Clinical Trials Office - Rush University Medical Center 312-942-5498 clinical_trials@rush.edu | |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Sharad N. Salvi 708-684-4094 | |
| Advocate Lutheran General Cancer Care Center | Recruiting |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care 847-384-3621 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| Children's Hospital of New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medical Center | Recruiting |
| Bangor, Maine, United States, 04401 | |
| Contact: Clinical Trials Office - CancerCare of Maine 207-973-4274 | |
| United States, Massachusetts | |
| Floating Hospital for Children at Tufts - New England Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Contact Person 617-636-5535 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Helen DeVos Children's Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Clinical Trials Office - Helen DeVos Children's Hospital 616-391-3050 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65203 | |
| Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440 | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine L. Hetherington 816-234-3265 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-4118 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89109-2306 | |
| Contact: Jonathan Bernstein 702-732-1493 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| St. Barnabas Medical Center Cancer Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce 973-322-2470 | |
| Overlook Hospital | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: John J. Gregory 973-971-6720 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact: Mary A. Bonilla 973-754-3349 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Brookdale University Hospital and Medical Center | Recruiting |
| Brooklyn, New York, United States, 11212 | |
| Contact: Clinical Trials Office - Brookdale University Hospital and Med 718-240-5807 | |
| Brooklyn Hospital Center | Recruiting |
| Brooklyn, New York, United States, 11201-5493 | |
| Contact: Swayamprabha Sadanandan 718-250-6074 | |
| Maimonides Cancer Center at Maimonides Medical Center | Recruiting |
| Brooklyn, New York, United States, 11219 | |
| Contact: Contact Person 718-765-2520 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Contact Person 516-663-9500 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Elizabeth A. Raetz 212-263-8400 | |
| Stony Brook University Cancer Center | Recruiting |
| Stony Brook, New York, United States, 11794-9446 | |
| Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mehmet F. Ozkaynak 914-493-7997 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, Ohio | |
| Akron Children's Hospital | Recruiting |
| Akron, Ohio, United States, 44308-1062 | |
| Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Laura T. Martin 614-722-3582 | |
| Dayton Children's - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett H. Broxson 937-641-3111 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| Tod Children's Hospital | Recruiting |
| Youngstown, Ohio, United States, 44501 | |
| Contact: Clinical Trials Office - Tod Children's Hospital 330-884-3955 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Gregory B. Kirkpatrick 918-502-6720 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Philip M. Monteleone 484-884-3333 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Contact: Elizabeth Fox 267-425-3010 | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-7056 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| T.C. Thompson Children's Hospital | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Manoo G. Bhakta 423-778-7289 | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37901 | |
| Contact: Ray C. Pais 865-541-8266 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Osvaldo Regueira 806-354-5434x282 | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022 | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: Clinical Trials Office - Driscoll Children's Hospital 361-694-5311 | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-6647x4439 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-4840 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Jaime Estrada 210-575-7268 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78207 | |
| Contact: Paul J. Thomas 210-704-2187 | |
| CCOP - Scott and White Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Guy H. Grayson 254-724-2006 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042-3300 | |
| Contact: Clinical Trials Office - Inova Fairfax Hospital 703-208-6650 | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Julie R. Park 206-987-2106 | |
| Providence Cancer Center at Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99220-2555 | |
| Contact: Judy L. Felgenhauer 509-474-2777 | |
| Madigan Army Medical Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Contact: Melissa A. Forouhar 253-968-6144 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | Recruiting |
| Charleston, West Virginia, United States, 25302 | |
| Contact: Allen R. Chauvenet 304-388-1552 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine H. Cole 011-6189340-8238 | |
| Canada, Alberta | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Sunil Jayantilal` S. Desai 780-407-8829 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Caron Strahlendorf 604-875-3576 | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Contact: Margaret C. Yhap 902-470-8778 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Mariana P. Silva 613-5496666x3833 | |
| Children's Hospital of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Anne E. Cairney 519-685-8494 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sylvain Baruchel 416-813-7795 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | Recruiting |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Contact: Mansoor M. Haq 306-766-2498 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Christopher Mpofu 306-655-2744 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Smita Bhatia, MD, MPH | Beckman Research Institute |
| Investigator: | Mary Relling, PharmD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00268528 History of Changes |
| Other Study ID Numbers: | CDR0000459748, COG-AALL03N1 |
| Study First Received: | December 20, 2005 |
| Last Updated: | April 2, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood acute lymphoblastic leukemia in remission |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Methotrexate Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Folic Acid Antagonists Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013