Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
10. september 2014 opdateret af: Children's Oncology Group
A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine, in terms of event-free survival, in patients with advanced anaplastic large cell lymphoma.
- Compare overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Correlate biological tumor characteristics and outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine (VBL).
- Induction therapy: All Patients receive doxorubicin IV over 15 minutes on days 1 and 22; vincristine IV on days 1, 8, 15, 22, and 29; oral prednisone 3 times daily on days 1-28; and intrathecal (IT) methotrexate on days 1, 8, and 22 (patients with central nervous system (CNS) disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36).
Patients undergo restaging after Induction such that consolidation therapy is started on day 43. All patients with complete response (CR), complete response unconfirmed (CRu) or partial response (PR) proceed to Consolidation based on CT or MRI scans at the end of induction (week 6). All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study. Follow-up data will be required unless consent is withdrawn.
Standard APO (Arm I): Patients receive course-specific regimens without vinblastine.
- Courses 1-3: Patients receive doxorubicin IV over 15 minutes, vincristine IV, and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5.
- Courses 4-5: Patients receive doxorubicin, vincristine, prednisone, and mercaptopurine as in courses 1-3.
- Courses 6-15: Patients receive vincristine, prednisone, and mercaptopurine as in courses 1-3 and methotrexate IV on day 1.
Consolidation with vinblastine (Arm II): Patients receive course-specific regimens including vinblastine.
- Courses 1-3: Patients receive doxorubicin, methotrexate IT, prednisone, and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15.
- Courses 4-5: Patients receive doxorubicin, prednisone, and mercaptopurine as in arm I and vinblastine as in arm II (courses 1-3).
- Courses 6-15: Patients receive prednisone and mercaptopurine as in arm I, vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1.
In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
129
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Westmead, New South Wales, Australien, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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London, Ontario, Canada, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forenede Stater, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, Forenede Stater, 93638-8762
- Children's Hospital Central California
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Sacramento, California, Forenede Stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Forenede Stater, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Forenede Stater, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Forenede Stater, 94305-5824
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Forenede Stater, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital
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Miami, Florida, Forenede Stater, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forenede Stater, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Forenede Stater, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Forenede Stater, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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St. Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Forenede Stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Forenede Stater, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Forenede Stater, 31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Forenede Stater, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forenede Stater, 60614
- Children's Memorial Hospital - Chicago
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Christ Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forenede Stater, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Forenede Stater, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Forenede Stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Springfield, Massachusetts, Forenede Stater, 01199-0001
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Forenede Stater, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114-4113
- Children's Hospital
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Omaha, Nebraska, Forenede Stater, 68198-6805
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Forenede Stater, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131-5636
- University of New Mexico Cancer Center
-
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New York
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forenede Stater, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Forenede Stater, 11040
- Schneider Children's Hospital
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
Valhalla, New York, Forenede Stater, 10595
- New York Medical College
-
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North Carolina
-
Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospitals - Memorial Campus
-
Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Forenede Stater, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Forenede Stater, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
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Ohio
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Akron, Ohio, Forenede Stater, 44308-1062
- Akron Children's Hospital
-
Cincinnati, Ohio, Forenede Stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44106-5000
- Rainbow Babies and Children's Hospital
-
Columbus, Ohio, Forenede Stater, 43205-2696
- Nationwide Children's Hospital
-
Dayton, Ohio, Forenede Stater, 45404-1815
- Children's Medical Center - Dayton
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
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Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Cancer Institute
-
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Oregon
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Portland, Oregon, Forenede Stater, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Hospital Cancer Center
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South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Forenede Stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Austin, Texas, Forenede Stater, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forenede Stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Houston, Texas, Forenede Stater, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
Houston, Texas, Forenede Stater, 77030-2399
- Baylor University Medical Center - Houston
-
Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Forenede Stater, 78229-3993
- Methodist Children's Hospital of South Texas
-
San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
-
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113-1100
- Primary Children's Medical Center
-
-
Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
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Virginia
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Norfolk, Virginia, Forenede Stater, 23507-1971
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Forenede Stater, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Forenede Stater, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
-
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Forenede Stater, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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Tacoma, Washington, Forenede Stater, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25302
- West Virginia University Health Sciences Center - Charleston
-
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
-
-
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Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
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-
-
-
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Bern, Schweiz, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Schweiz, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Schweiz, 1011
- Swiss Pediatric Oncology Group Lausanne
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 20 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
Newly diagnosed advanced anaplastic large cell lymphoma
- Cluster of differentiation antigen 30 (CD30+)
- Murphy stage III or IV
- No B-cell large cell lymphoma
- No disease limited to the skin (regardless of how wide-spread)
PATIENT CHARACTERISTICS:
Age
- Under 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma)
Renal
- Not specified
Cardiovascular
- Shortening fraction (SF) at least 27% by echocardiogram OR
- Ejection fraction (EF) at least 50% by radionuclide angiogram
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior steroids for management of a mediastinal mass allowed
Radiotherapy
- Prior limited-dose radiotherapy for a mediastinal mass allowed
Surgery
- Not specified
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Standard APO with Vincristine (Arm I )
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5.
In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3.
In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1.
Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
Givet IV
Givet IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
Eksperimentel: Consolidation with Vinblastine
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15.
In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3).
In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1.
Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
Givet IV
Given by mouth
Given IV and intrathecally
Given by mouth
Givet IV
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Event-free Survival (EFS)
Tidsramme: From first enrollment up to 3 years.
|
Percentage of EFS patients.
This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause.
To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05)
and the lower critical values are based on testing the alternative hypothesis at 0.005 level.
|
From first enrollment up to 3 years.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Jacqueline Kraveka, DO, Medical University of South Carolina
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2003
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
6. maj 2003
Først indsendt, der opfyldte QC-kriterier
6. maj 2003
Først opslået (Skøn)
7. maj 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, T-celle
- Lymfom
- Lymfom, storcellet, anaplastisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Dermatologiske midler
- Antibiotika, antineoplastisk
- Reproduktive kontrolmidler
- Abortfremkaldende midler, ikke-steroide
- Aborterende midler
- Folinsyreantagonister
- Prednison
- Doxorubicin
- Liposomal doxorubicin
- Methotrexat
- Vincristine
- Mercaptopurin
- Vinblastin
Andre undersøgelses-id-numre
- ANHL0131
- CDR0000298777 (Anden identifikator: Clinical Trials.gov)
- COG-ANHL0131 (Anden identifikator: Children's Oncology Group)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .