Clinical TrialID 7237

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

NCT00059839

Lymphoma

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
7237
Evidence Id
7237
Core Evidence Id
7237
Source Clinical Trial Id
7227
Herb2 Clinical Trial Id
HBCT007227
Nct Id
NCT00059839
Title
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Status
Completed
Phase
Phase 3
Study Result
Yes
Study Condition
Lymphoma
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: doxorubicin hydrochloride|DRUG: mercaptopurine|DRUG: methotrexate|DRUG: prednisone|DRUG: vinblastine sulfate|DRUG: vincristine sulfate
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult
Enrollment
129
Outcome Measure
Event-free Survival (EFS), 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.
Sponsor Collaborator
Children's Oncology Group|National Cancer Institute (NCI)
Funded By
NETWORK
Location
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, 35294, United States|Phoenix Children's Hospital, Phoenix, Arizona, 85016-7710, United States|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Southern California Permanente Medical Group, Downey, California, 90027, United States|Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States|Children's Hospital Central California, Madera, California, 93638-8762, United States|Children's Hospital of Orange County, Orange, California, 92868, United States|Sutter Cancer Center, Sacramento, California, 95816, United States|Kaiser Permanente Medical Center - Oakland, Sacramento, California, 95825, United States|Rady Children's Hospital - San Diego, San Diego, California, 92123-4282, United States|UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94115, United States|Stanford Cancer Center, Stanford, California, 94305-5824, United States|Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado, 80045, United States|Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States|Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, 06360-2875, United States|Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19803, United States|Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States|Broward General Medical Center Cancer Center, Fort Lauderdale, Florida, 33316, United States|Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, 33901, United States|Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States|Nemours Children's Clinic, Jacksonville, Florida, 32207, United States|University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, 33136, United States|Miami Children's Hospital, Miami, Florida, 33155, United States|Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176, United States|Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, 32803-1273, United States|M.D. Anderson Cancer Center at Orlando, Orlando, Florida, 32806, United States|Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, 32504, United States|All Children's Hospital, St. Petersburg, Florida, 33701, United States|St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, 33607, United States|Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, 33407, United States|Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States|MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-3730, United States|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31403-3089, United States|Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States|Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, 83712-6297, United States|Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States|University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453, United States|Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068-1174, United States|Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States|Simmons Cooper Cancer Institute, Springfield, Illinois, 62794-9677, United States|Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202-5289, United States|St. Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States|Blank Children's Hospital, Des Moines, Iowa, 50309, United States|Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1002, United States|Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, 40536-0093, United States|Kosair Children's Hospital, Louisville, Kentucky, 40232, United States|Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, 71315-3198, United States|Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, 21215, United States|Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, 01199-0001, United States|C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, 48109-0286, United States|Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, 49503-2560, United States|Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, 48236, United States|CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-5381, United States|Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 48910, United States|Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, 55404, United States|Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, 55455, United States|Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States|University of Mississippi Cancer Clinic, Jackson, Mississippi, 39216-4505, United States|Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States|Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri, 63110, United States|Children's Hospital, Omaha, Nebraska, 68114-4113, United States|UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-6805, United States|CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, 89109-2306, United States|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States|Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, 07601, United States|Overlook Hospital, Morristown, New Jersey, 07962, United States|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States|Newark Beth Israel Medical Center, Newark, New Jersey, 07112, United States|St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87131-5636, United States|Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States|Brooklyn Hospital Center, Brooklyn, New York, 11201-5493, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States|Schneider Children's Hospital, New Hyde Park, New York, 11040, United States|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, 10032, United States|James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States|SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States|New York Medical College, Valhalla, New York, 10595, United States|Mission Hospitals - Memorial Campus, Asheville, North Carolina, 28801, United States|Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States|Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233-3549, United States|Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States|Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, 27835-6028, United States|Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157-1096, United States|CCOP - MeritCare Hospital, Fargo, North Dakota, 58122, United States|Akron Children's Hospital, Akron, Ohio, 44308-1062, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States|Rainbow Babies and Children's Hospital, Cleveland, Ohio, 44106-5000, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States|Nationwide Children's Hospital, Columbus, Ohio, 43205-2696, United States|Children's Medical Center - Dayton, Dayton, Ohio, 45404-1815, United States|Toledo Hospital, Toledo, Ohio, 43606, United States|Medical University of Ohio Cancer Center, Toledo, Ohio, 43614, United States|Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104, United States|Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, 97227, United States|Oregon Health and Science University Cancer Institute, Portland, Oregon, 97239-3098, United States|Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, 18017, United States|Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, 17822-0001, United States|Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States|St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States|Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, 02903, United States|Greenville Hospital Cancer Center, Greenville, South Carolina, 29605, United States|Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, 57117-5039, United States|T.C. Thompson Children's Hospital, Chattanooga, Tennessee, 37403, United States|East Tennessee Children's Hospital, Knoxville, Tennessee, 37901, United States|St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States|Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, 79106, United States|Dell Children's Medical Center of Central Texas, Austin, Texas, 78723, United States|Driscoll Children's Hospital, Corpus Christi, Texas, 78411, United States|Medical City Dallas Hospital, Dallas, Texas, 75230, United States|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390, United States|Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104, United States|Baylor University Medical Center - Houston, Houston, Texas, 77030-2399, United States|M. D. Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States|Covenant Children's Hospital, Lubbock, Texas, 79410, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States|Methodist Children's Hospital of South Texas, San Antonio, Texas, 78229-3993, United States|Primary Children's Medical Center, Salt Lake City, Utah, 84113-1100, United States|Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, 05401, United States|Children's Hospital of The King's Daughters, Norfolk, Virginia, 23507-1971, United States|Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, 23298-0037, United States|Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia, 24014, United States|Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, 98105, United States|Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, 99220-2555, United States|Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma, Washington, 98405, United States|West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, 25302, United States|St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, 54307-3508, United States|Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449, United States|Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, 2145, Australia|Royal Children's Hospital, Brisbane, Queensland, 4029, Australia|Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia|Alberta Children's Hospital, Calgary, Alberta, T3B 6A8, Canada|University of Alberta Hospital, Edmonton, Alberta, T6G 1Z2, Canada|Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, V6H 3V4, Canada|CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada|Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, A1B 3V6, Canada|IWK Health Centre, Halifax, Nova Scotia, B3K 6R8, Canada|McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada|Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, K7L 2V7, Canada|Children's Hospital of Western Ontario, London, Ontario, N6A 5W9, Canada|Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, H3H 1P3, Canada|Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada|Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, S4T 7T1, Canada|Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, S7N 4H4, Canada|Centre Hospitalier Universitaire de Quebec, Quebec, G1V 4G2, Canada|San Jorge Children's Hospital, Santurce, 00912, Puerto Rico|Swiss Pediatric Oncology Group Bern, Bern, 3010, Switzerland|Swiss Pediatric Oncology Group Geneva, Geneva, 1205, Switzerland|Swiss Pediatric Oncology Group Lausanne, Lausanne, 1011, Switzerland
Other Id
ANHL0131|CDR0000298777|COG-ANHL0131
Start Date
2003-11
Primary Completion Date
2009-12
Completion Date
2014-07
First Posted
2003-05-07
Results First Posted
2013-10-08
Last Update Posted
2014-09-22
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00059839
Title Cn
Title En
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
Bilingual Status
semi_complete