Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
10 września 2014 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
129
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Calgary, Alberta, Kanada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Kanada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Kanada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Kanada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Kanada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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London, Ontario, Kanada, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Kanada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Santurce, Portoryko, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Stany Zjednoczone, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Stany Zjednoczone, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, Stany Zjednoczone, 93638-8762
- Children's Hospital Central California
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Orange, California, Stany Zjednoczone, 92868
- Children's Hospital of Orange County
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Sacramento, California, Stany Zjednoczone, 95816
- Sutter Cancer Center
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Sacramento, California, Stany Zjednoczone, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Stany Zjednoczone, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Stany Zjednoczone, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Stany Zjednoczone, 94305-5824
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Stany Zjednoczone, 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, Stany Zjednoczone, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Stany Zjednoczone, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Stany Zjednoczone, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Stany Zjednoczone, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Stany Zjednoczone, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Stany Zjednoczone, 32207
- Nemours Children's Clinic
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Stany Zjednoczone, 33155
- Miami Children's Hospital
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Miami, Florida, Stany Zjednoczone, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Stany Zjednoczone, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Stany Zjednoczone, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Stany Zjednoczone, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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St. Petersburg, Florida, Stany Zjednoczone, 33701
- All Children's Hospital
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Tampa, Florida, Stany Zjednoczone, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Stany Zjednoczone, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Stany Zjednoczone, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Stany Zjednoczone, 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, Stany Zjednoczone, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Stany Zjednoczone, 60614
- Children's Memorial Hospital - Chicago
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Oak Lawn, Illinois, Stany Zjednoczone, 60453
- Advocate Christ Medical Center
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Park Ridge, Illinois, Stany Zjednoczone, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Stany Zjednoczone, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Stany Zjednoczone, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stany Zjednoczone, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Stany Zjednoczone, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Stany Zjednoczone, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Springfield, Massachusetts, Stany Zjednoczone, 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, Stany Zjednoczone, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Stany Zjednoczone, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Stany Zjednoczone, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Stany Zjednoczone, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Stany Zjednoczone, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Stany Zjednoczone, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Stany Zjednoczone, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Stany Zjednoczone, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68114-4113
- Children's Hospital
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Omaha, Nebraska, Stany Zjednoczone, 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, Stany Zjednoczone, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Stany Zjednoczone, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Stany Zjednoczone, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Stany Zjednoczone, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Stany Zjednoczone, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Stany Zjednoczone, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Stany Zjednoczone, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Stany Zjednoczone, 11040
- Schneider Children's Hospital
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New York, New York, Stany Zjednoczone, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Stany Zjednoczone, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Syracuse, New York, Stany Zjednoczone, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Stany Zjednoczone, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Stany Zjednoczone, 28801
- Mission Hospitals - Memorial Campus
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Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stany Zjednoczone, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Stany Zjednoczone, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Winston-Salem, North Carolina, Stany Zjednoczone, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Stany Zjednoczone, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Stany Zjednoczone, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stany Zjednoczone, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Stany Zjednoczone, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Stany Zjednoczone, 45404-1815
- Children's Medical Center - Dayton
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Toledo, Ohio, Stany Zjednoczone, 43606
- Toledo Hospital
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Toledo, Ohio, Stany Zjednoczone, 43614
- Medical University of Ohio Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Portland, Oregon, Stany Zjednoczone, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Bethlehem, Pennsylvania, Stany Zjednoczone, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Stany Zjednoczone, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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-
South Carolina
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Stany Zjednoczone, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Stany Zjednoczone, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Stany Zjednoczone, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Stany Zjednoczone, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Austin, Texas, Stany Zjednoczone, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Stany Zjednoczone, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Stany Zjednoczone, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Stany Zjednoczone, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Stany Zjednoczone, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stany Zjednoczone, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Houston, Texas, Stany Zjednoczone, 77030-2399
- Baylor University Medical Center - Houston
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Lubbock, Texas, Stany Zjednoczone, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Stany Zjednoczone, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Stany Zjednoczone, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Stany Zjednoczone, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norfolk, Virginia, Stany Zjednoczone, 23507-1971
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Stany Zjednoczone, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Stany Zjednoczone, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Stany Zjednoczone, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Stany Zjednoczone, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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Tacoma, Washington, Stany Zjednoczone, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
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West Virginia
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Charleston, West Virginia, Stany Zjednoczone, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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-
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Bern, Szwajcaria, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Szwajcaria, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Szwajcaria, 1011
- Swiss Pediatric Oncology Group Lausanne
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
Nie starszy niż 20 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Biorąc pod uwagę IV
Biorąc pod uwagę IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
Eksperymentalny: 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.
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Biorąc pod uwagę IV
Given by mouth
Given IV and intrathecally
Given by mouth
Biorąc pod uwagę IV
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Event-free Survival (EFS)
Ramy czasowe: From first enrollment up to 3 years.
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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.
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From first enrollment up to 3 years.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Jacqueline Kraveka, DO, Medical University of South Carolina
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2003
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2009
Ukończenie studiów (Rzeczywisty)
1 lipca 2014
Daty rejestracji na studia
Pierwszy przesłany
6 maja 2003
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 maja 2003
Pierwszy wysłany (Oszacować)
7 maja 2003
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
22 września 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 września 2014
Ostatnia weryfikacja
1 września 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Nowotwory
- Zaburzenia limfoproliferacyjne
- Choroby limfatyczne
- Zaburzenia immunoproliferacyjne
- Chłoniak nieziarniczy
- Chłoniak, T-komórkowy
- Chłoniak
- Chłoniak wielkokomórkowy, anaplastyczny
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Antymetabolity, przeciwnowotworowe
- Antymetabolity
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Glikokortykosteroidy
- Hormony
- Hormony, substytuty hormonów i antagoniści hormonów
- Środki przeciwnowotworowe, hormonalne
- Środki przeciwnowotworowe, Fitogenne
- Inhibitory topoizomerazy II
- Inhibitory topoizomerazy
- Środki dermatologiczne
- Antybiotyki, Przeciwnowotworowe
- Środki kontroli reprodukcji
- Środki poronne, niesteroidowe
- Środki poronne
- Antagoniści kwasu foliowego
- Prednizon
- Doksorubicyna
- Liposomalna doksorubicyna
- Metotreksat
- Winkrystyna
- Merkaptopuryna
- Winblastyna
Inne numery identyfikacyjne badania
- ANHL0131
- CDR0000298777 (Inny identyfikator: Clinical Trials.gov)
- COG-ANHL0131 (Inny identyfikator: Children's Oncology Group)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .