Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
10 de setembro de 2014 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
129
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New South Wales
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Westmead, New South Wales, Austrália, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
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Queensland
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Brisbane, Queensland, Austrália, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Austrália, 6001
- Princess Margaret Hospital for Children
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Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Calgary, Alberta, Canadá, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canadá, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canadá, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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London, Ontario, Canadá, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
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Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Estados Unidos, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Estados Unidos, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Estados Unidos, 94305-5824
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Estados Unidos, 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, Estados Unidos, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Estados Unidos, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Miami, Florida, Estados Unidos, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Estados Unidos, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Estados Unidos, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Estados Unidos, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Estados Unidos, 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, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Estados Unidos, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Christ Medical Center
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Estados Unidos, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Estados Unidos, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Estados Unidos, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Estados Unidos, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Estados Unidos, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Springfield, Massachusetts, Estados Unidos, 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, Estados Unidos, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Estados Unidos, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Estados Unidos, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114-4113
- Children's Hospital
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Omaha, Nebraska, Estados Unidos, 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, Estados Unidos, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Estados Unidos, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Estados Unidos, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hospital
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
- Mission Hospitals - Memorial Campus
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Estados Unidos, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Estados Unidos, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Winston-Salem, North Carolina, Estados Unidos, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Estados Unidos, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Estados Unidos, 45404-1815
- Children's Medical Center - Dayton
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Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Portland, Oregon, Estados Unidos, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Estados Unidos, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Austin, Texas, Estados Unidos, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Estados Unidos, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Estados Unidos, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Houston, Texas, Estados Unidos, 77030-2399
- Baylor University Medical Center - Houston
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Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Estados Unidos, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507-1971
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Estados Unidos, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Estados Unidos, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Estados Unidos, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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Tacoma, Washington, Estados Unidos, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Santurce, Porto Rico, 00912
- San Jorge Children's Hospital
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Bern, Suíça, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suíça, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Suíça, 1011
- Swiss Pediatric Oncology Group Lausanne
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 20 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
Dado IV
Dado IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
Experimental: 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.
|
Dado IV
Given by mouth
Given IV and intrathecally
Given by mouth
Dado IV
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Event-free Survival (EFS)
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Jacqueline Kraveka, DO, Medical University of South Carolina
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2003
Conclusão Primária (Real)
1 de dezembro de 2009
Conclusão do estudo (Real)
1 de julho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
6 de maio de 2003
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de maio de 2003
Primeira postagem (Estimativa)
7 de maio de 2003
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
22 de setembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2014
Última verificação
1 de setembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Linfoma Não-Hodgkin
- Linfoma de Células T
- Linfoma
- Linfoma de Células Grandes Anaplásico
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Agentes Antineoplásicos Fitogênicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Agentes dermatológicos
- Antibióticos, Antineoplásicos
- Agentes de Controle Reprodutivo
- Agentes abortivos, não esteróides
- Agentes abortivos
- Antagonistas do ácido fólico
- Prednisona
- Doxorrubicina
- Doxorrubicina lipossomal
- Metotrexato
- Vincristina
- Mercaptopurina
- Vinblastina
Outros números de identificação do estudo
- ANHL0131
- CDR0000298777 (Outro identificador: Clinical Trials.gov)
- COG-ANHL0131 (Outro identificador: Children's Oncology Group)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .