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Study to Assess Compliance With Long-Term MercaptopurineTreatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: December 20, 2005   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00268528
  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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: 6-Mercaptopurine Methotrexate Mercaptopurine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL

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)
Detailed Description:

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.

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

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

  Hide Study Locations
Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer     205-934-0309        
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica L. Boklan     602-546-0920        
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
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        
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas     323-361-2529        
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    
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Recruiting
Long Beach, California, United States, 90801
Contact: Jerry Z. Finklestein     562-492-1062        
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
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        
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        
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048-1865
Contact: Carole G. Hurvitz     310-423-4423        
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90027
Contact: Robert Cooper     323-783-5307        
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
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        
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        
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Maloney     720-777-6673        
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06360-2875
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can     800-579-7822        
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        
United States, Florida
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Gregory Hale     727-767-4176        
Baptist-South Miami Regional Cancer Program Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani     305-274-1662        
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        
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        
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 Sandler     904-697-3793        
Sacred Heart Cancer Center at Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center     850-416-4611        
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        
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        
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    
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912-3730
Contact: Colleen McDonough     706-721-3626        
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein     312-908-0710        
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
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Sharad 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        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
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
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        
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center     504-988-6121        
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: Cynthia S. Kretschmar     617-636-5535        
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503-2560
Contact: David S. Dickens     616-391-2086        
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        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
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
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine Hetherington     816-234-3265        
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-4894        
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     702-732-0971        
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
St. Joseph's Hospital and Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary Ann Bonilla     973-754-3349        
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center     973-926-3136        
Overlook Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Hazem Mahmoud     973-971-6720        
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
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    
Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201-5493
Contact: Swayamprabha Sadanandan     718-250-6074        
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        
Maimonides Cancer Center at Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Ludovico Guarini     718-283-8173        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
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        
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Fevzi Ozkaynak     914-493-7997        
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Contact Person     516-663-9500        
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
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        
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        
Children's Medical Center - Dayton Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett Broxson     937-641-3111        
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Amanda Termuhlen     614-722-3552        
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: John Letterio     216-844-3345        
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital     419-824-1842        
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory Kirkpatrick     918-502-6720        
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp     405-271-5311        
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
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Richard Aplenc     267-426-7252        
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-5573        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone     484-884-3347        
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C     401-444-1488        
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
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
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Ray C. Pais     865-541-8266        
T.C. Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta     423-778-7289        
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
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030-2399
Contact: Patrick A. Thompson     832-824-4029        
CCOP - Scott and White Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Arlynn F. Mulne     254-724-2006        
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: Michael S. Grimley     210-575-7268        
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        
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        
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        
Texas Tech University Health Sciences Center School of Medicine - Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Curtis W. Turner     806-354-5434X264        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Paul Thomas     210-704-2187        
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 Park     206-987-1947        
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar     253-986-6144        
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy Felgenhauer     509-474-2777        
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25302
Contact: Allen Chauvenet     304-388-1552        
United States, Wisconsin
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: Bruce M. Camitta     414-456-4106        
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        
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine Cole     011-6189340-8238        
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sunil Desai     780-407-8829        
Canada, British Columbia
Children's & Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Mason Bond     604-875-2322        
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
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: A. E.L. Cairney     519-685-8494        
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel     416-813-7795        
Canada, Quebec
Montreal Children's Hospital at McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon Abish     514-412-4400x22219        
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: Kaiser Ali     306-655-2744        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Smita Bhatia, MD Beckman Research Institute
Investigator: Mary Relling, PharmD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000459748, COG-AALL03N1
Study First Received: December 20, 2005
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00268528     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission

Study placed in the following topic categories:
Acute Lymphoblastic Leukemia, Childhood
Antimetabolites
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
6-Mercaptopurine
Folic Acid Antagonists
Immunosuppressive Agents
Folic Acid
Leukemia
Lymphatic Diseases
Methotrexate
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
6-Mercaptopurine
Reproductive Control Agents
Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Antirheumatic Agents
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 12, 2009