Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
10 settembre 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
129
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
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London, Ontario, Canada, N6A 5W9
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
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Santurce, Porto Rico, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Arizona
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Phoenix, Arizona, Stati Uniti, 85016-7710
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Stati Uniti, 90027
- Southern California Permanente Medical Group
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Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Madera, California, Stati Uniti, 93638-8762
- Children's Hospital Central California
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Orange, California, Stati Uniti, 92868
- Children's Hospital of Orange County
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Sacramento, California, Stati Uniti, 95816
- Sutter Cancer Center
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Sacramento, California, Stati Uniti, 95825
- Kaiser Permanente Medical Center - Oakland
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San Diego, California, Stati Uniti, 92123-4282
- Rady Children's Hospital - San Diego
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San Francisco, California, Stati Uniti, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, Stati Uniti, 94305-5824
- Stanford Cancer Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Children's Hospital Center for Cancer and Blood Disorders
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Stati Uniti, 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, Stati Uniti, 19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Stati Uniti, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Stati Uniti, 33901
- Lee Cancer Care of Lee Memorial Health System
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Hollywood, Florida, Stati Uniti, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jacksonville, Florida, Stati Uniti, 32207
- Nemours Children's Clinic
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Miami, Florida, Stati Uniti, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
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Miami, Florida, Stati Uniti, 33155
- Miami Children's Hospital
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Miami, Florida, Stati Uniti, 33176
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Stati Uniti, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
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Orlando, Florida, Stati Uniti, 32806
- M.D. Anderson Cancer Center at Orlando
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Pensacola, Florida, Stati Uniti, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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St. Petersburg, Florida, Stati Uniti, 33701
- All Children's Hospital
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Tampa, Florida, Stati Uniti, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
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West Palm Beach, Florida, Stati Uniti, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, Stati Uniti, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
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Savannah, Georgia, Stati Uniti, 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, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Stati Uniti, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Stati Uniti, 60614
- Children's Memorial Hospital - Chicago
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Oak Lawn, Illinois, Stati Uniti, 60453
- Advocate Christ Medical Center
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Park Ridge, Illinois, Stati Uniti, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Peoria, Illinois, Stati Uniti, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Stati Uniti, 62794-9677
- Simmons Cooper Cancer Institute
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stati Uniti, 46260
- St. Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, Stati Uniti, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Stati Uniti, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, Stati Uniti, 40232
- Kosair Children's Hospital
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Louisiana
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Alexandria, Louisiana, Stati Uniti, 71315-3198
- Tulane Cancer Center Office of Clinical Research
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Maryland
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Baltimore, Maryland, Stati Uniti, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
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Springfield, Massachusetts, Stati Uniti, 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, Stati Uniti, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
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Detroit, Michigan, Stati Uniti, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Stati Uniti, 49503-2560
- Butterworth Hospital at Spectrum Health
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Kalamazoo, Michigan, Stati Uniti, 49007-5381
- CCOP - Kalamazoo
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Lansing, Michigan, Stati Uniti, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Stati Uniti, 55455
- Masonic Cancer Center at University of Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Cancer Clinic
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Stati Uniti, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Stati Uniti, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114-4113
- Children's Hospital
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Omaha, Nebraska, Stati Uniti, 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, Stati Uniti, 89109-2306
- CCOP - Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center Cancer Center
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Morristown, New Jersey, Stati Uniti, 07962
- Overlook Hospital
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New Brunswick, New Jersey, Stati Uniti, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Stati Uniti, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Stati Uniti, 07503
- St. Joseph's Hospital and Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131-5636
- University of New Mexico Cancer Center
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New York
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Bronx, New York, Stati Uniti, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Stati Uniti, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Stati Uniti, 11040
- Schneider Children's Hospital
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Stati Uniti, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
- Mission Hospitals - Memorial Campus
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Charlotte, North Carolina, Stati Uniti, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stati Uniti, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Stati Uniti, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
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Winston-Salem, North Carolina, Stati Uniti, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
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Ohio
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Akron, Ohio, Stati Uniti, 44308-1062
- Akron Children's Hospital
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Cincinnati, Ohio, Stati Uniti, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stati Uniti, 44106-5000
- Rainbow Babies and Children's Hospital
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Columbus, Ohio, Stati Uniti, 43205-2696
- Nationwide Children's Hospital
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Dayton, Ohio, Stati Uniti, 45404-1815
- Children's Medical Center - Dayton
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Toledo, Ohio, Stati Uniti, 43606
- Toledo Hospital
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Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma University Cancer Institute
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Oregon
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Portland, Oregon, Stati Uniti, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
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Portland, Oregon, Stati Uniti, 97239-3098
- Oregon Health and Science University Cancer Institute
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Pennsylvania
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Bethlehem, Pennsylvania, Stati Uniti, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, Stati Uniti, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hershey, Pennsylvania, Stati Uniti, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Stati Uniti, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29605
- Greenville Hospital Cancer Center
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37403
- T.C. Thompson Children's Hospital
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Knoxville, Tennessee, Stati Uniti, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Stati Uniti, 38105
- St. Jude Children's Research Hospital
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Austin, Texas, Stati Uniti, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Stati Uniti, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Stati Uniti, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Stati Uniti, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Stati Uniti, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stati Uniti, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Houston, Texas, Stati Uniti, 77030-2399
- Baylor University Medical Center - Houston
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Lubbock, Texas, Stati Uniti, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Stati Uniti, 78229-3993
- Methodist Children's Hospital of South Texas
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San Antonio, Texas, Stati Uniti, 78207
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84113-1100
- Primary Children's Medical Center
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Vermont
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Burlington, Vermont, Stati Uniti, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507-1971
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Stati Uniti, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Roanoke, Virginia, Stati Uniti, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Stati Uniti, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Spokane, Washington, Stati Uniti, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
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Tacoma, Washington, Stati Uniti, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25302
- West Virginia University Health Sciences Center - Charleston
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Bern, Svizzera, 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Svizzera, 1205
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Svizzera, 1011
- Swiss Pediatric Oncology Group Lausanne
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 20 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Dato IV
Dato IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
Sperimentale: 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.
|
Dato IV
Given by mouth
Given IV and intrathecally
Given by mouth
Dato IV
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Event-free Survival (EFS)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Jacqueline Kraveka, DO, Medical University of South Carolina
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2003
Completamento primario (Effettivo)
1 dicembre 2009
Completamento dello studio (Effettivo)
1 luglio 2014
Date di iscrizione allo studio
Primo inviato
6 maggio 2003
Primo inviato che soddisfa i criteri di controllo qualità
6 maggio 2003
Primo Inserito (Stima)
7 maggio 2003
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
22 settembre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 settembre 2014
Ultimo verificato
1 settembre 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma, cellule T
- Linfoma
- Linfoma, a grandi cellule, anaplastico
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antireumatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Agenti dermatologici
- Antibiotici, Antineoplastici
- Agenti di controllo riproduttivo
- Agenti abortivi, non steroidei
- Agenti abortivi
- Antagonisti dell'acido folico
- Prednisone
- Doxorubicina
- Doxorubicina liposomiale
- Metotrexato
- Vincristina
- Mercaptopurina
- Vinblastina
Altri numeri di identificazione dello studio
- ANHL0131
- CDR0000298777 (Altro identificatore: Clinical Trials.gov)
- COG-ANHL0131 (Altro identificatore: Children's Oncology Group)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .