Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
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
3 other identifiers
interventional
129
5 countries
159
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 lymphoma
Started Nov 2003
Typical duration for phase_3 lymphoma
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2003
CompletedFirst Posted
Study publicly available on registry
May 7, 2003
CompletedStudy Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedResults Posted
Study results publicly available
October 8, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 22, 2014
September 1, 2014
6.1 years
May 6, 2003
June 28, 2013
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Standard APO with Vincristine (Arm I )
EXPERIMENTALIn 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.
Consolidation with Vinblastine
EXPERIMENTALIn 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.
Interventions
Given IV
Given by mouth
Given IV and intrathecally
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (159)
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 D.C., 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
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
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, 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
Québec, 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
Related Publications (1)
Alexander S, Kraveka JM, Weitzman S, Lowe E, Smith L, Lynch JC, Chang M, Kinney MC, Perkins SL, Laver J, Gross TG, Weinstein H. Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group. Pediatr Blood Cancer. 2014 Dec;61(12):2236-42. doi: 10.1002/pbc.25187. Epub 2014 Aug 23.
PMID: 25156886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- STUDY CHAIR
Jacqueline Kraveka, DO
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2003
First Posted
May 7, 2003
Study Start
November 1, 2003
Primary Completion
December 1, 2009
Study Completion
July 1, 2014
Last Updated
September 22, 2014
Results First Posted
October 8, 2013
Record last verified: 2014-09