Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
10. září 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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 studie
Intervenční
Zápis (Aktuální)
129
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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New South Wales
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Westmead, New South Wales, Austrálie, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
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Queensland
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Brisbane, Queensland, Austrálie, 4029
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Austrálie, 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, Portoriko, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Spojené státy, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Spojené státy, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Spojené státy, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, Spojené státy, 93638-8762
- Children's Hospital Central California
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Orange, California, Spojené státy, 92868
- Children's Hospital of Orange County
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Sacramento, California, Spojené státy, 95816
- Sutter Cancer Center
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Sacramento, California, Spojené státy, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Spojené státy, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Spojené státy, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Spojené státy, 94305-5824
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Spojené státy, 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, Spojené státy, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Spojené státy, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Spojené státy, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Spojené státy, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Spojené státy, 32207
- Nemours Children's Clinic
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Miami, Florida, Spojené státy, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Spojené státy, 33155
- Miami Children's Hospital
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Miami, Florida, Spojené státy, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Spojené státy, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Spojené státy, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Spojené státy, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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St. Petersburg, Florida, Spojené státy, 33701
- All Children's Hospital
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Tampa, Florida, Spojené státy, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Spojené státy, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Spojené státy, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Spojené státy, 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, Spojené státy, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Spojené státy, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Spojené státy, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Spojené státy, 60614
- Children's Memorial Hospital - Chicago
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Oak Lawn, Illinois, Spojené státy, 60453
- Advocate Christ Medical Center
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Park Ridge, Illinois, Spojené státy, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Spojené státy, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Spojené státy, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Spojené státy, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Spojené státy, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Spojené státy, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Spojené státy, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Spojené státy, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Spojené státy, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Spojené státy, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Spojené státy, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Springfield, Massachusetts, Spojené státy, 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, Spojené státy, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Spojené státy, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Spojené státy, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Spojené státy, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Spojené státy, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Spojené státy, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Spojené státy, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Spojené státy, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Spojené státy, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Spojené státy, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Omaha, Nebraska, Spojené státy, 68114-4113
- Children's Hospital
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Omaha, Nebraska, Spojené státy, 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, Spojené státy, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Spojené státy, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Spojené státy, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Spojené státy, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Spojené státy, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Spojené státy, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Spojené státy, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Spojené státy, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Spojené státy, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Spojené státy, 11040
- Schneider Children's Hospital
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New York, New York, Spojené státy, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Spojené státy, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Syracuse, New York, Spojené státy, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Spojené státy, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Spojené státy, 28801
- Mission Hospitals - Memorial Campus
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Charlotte, North Carolina, Spojené státy, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Spojené státy, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Spojené státy, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Spojené státy, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Winston-Salem, North Carolina, Spojené státy, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Spojené státy, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Spojené státy, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Spojené státy, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Spojené státy, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Spojené státy, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Spojené státy, 45404-1815
- Children's Medical Center - Dayton
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Toledo, Ohio, Spojené státy, 43606
- Toledo Hospital
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Toledo, Ohio, Spojené státy, 43614
- Medical University of Ohio Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Spojené státy, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Portland, Oregon, Spojené státy, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Bethlehem, Pennsylvania, Spojené státy, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Spojené státy, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Spojené státy, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Spojené státy, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Spojené státy, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Spojené státy, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Spojené státy, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Spojené státy, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Austin, Texas, Spojené státy, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Spojené státy, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Spojené státy, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Spojené státy, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Spojené státy, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Spojené státy, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Houston, Texas, Spojené státy, 77030-2399
- Baylor University Medical Center - Houston
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Lubbock, Texas, Spojené státy, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Spojené státy, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Spojené státy, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Spojené státy, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Spojené státy, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norfolk, Virginia, Spojené státy, 23507-1971
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Spojené státy, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Spojené státy, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Spojené státy, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Spojené státy, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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Tacoma, Washington, Spojené státy, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
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West Virginia
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Charleston, West Virginia, Spojené státy, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Spojené státy, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Spojené státy, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Bern, Švýcarsko, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Švýcarsko, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Švýcarsko, 1011
- Swiss Pediatric Oncology Group Lausanne
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
Ne starší než 20 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
Vzhledem k tomu, IV
Vzhledem k tomu, IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
Experimentální: 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.
|
Vzhledem k tomu, IV
Given by mouth
Given IV and intrathecally
Given by mouth
Vzhledem k tomu, IV
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Event-free Survival (EFS)
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Jacqueline Kraveka, DO, Medical University of South Carolina
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2003
Primární dokončení (Aktuální)
1. prosince 2009
Dokončení studie (Aktuální)
1. července 2014
Termíny zápisu do studia
První předloženo
6. května 2003
První předloženo, které splnilo kritéria kontroly kvality
6. května 2003
První zveřejněno (Odhad)
7. května 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
22. září 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. září 2014
Naposledy ověřeno
1. září 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Novotvary
- Lymfoproliferativní poruchy
- Lymfatická onemocnění
- Imunoproliferativní poruchy
- Lymfom, Non-Hodgkin
- Lymfom, T-buňka
- Lymfom
- Lymfom, velkobuněčný, anaplastický
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Inhibitory syntézy nukleových kyselin
- Inhibitory enzymů
- Protizánětlivé látky
- Antirevmatika
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Glukokortikoidy
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Antineoplastická činidla, Hormonální
- Antineoplastické látky, fytogenní
- Inhibitory topoizomerázy II
- Inhibitory topoizomerázy
- Dermatologická činidla
- Antibiotika, antineoplastika
- Činidla pro kontrolu reprodukce
- Abortivní látky, nesteroidní
- Abortivní látky
- Antagonisté kyseliny listové
- Prednison
- Doxorubicin
- Lipozomální doxorubicin
- Methotrexát
- Vinkristine
- Merkaptopurin
- Vinblastin
Další identifikační čísla studie
- ANHL0131
- CDR0000298777 (Jiný identifikátor: Clinical Trials.gov)
- COG-ANHL0131 (Jiný identifikátor: Children's Oncology Group)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .