A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Disease-free Survival (DFS) in poor risk patients with DLBCL after achieving CR following first-line R-chemotherapy who receive RAD001 versus patients who receive matching placebo
DFS is the time from date of randomization to the date of event defined as the first documented recurrence of the disease or death due to any cause.
up to 5 years after the last patient is randomized
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CRAD001N2301
NCT00790036
July 2009
February 2015
Name | Location |
---|---|
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Oncology Partners Network | Cincinnati, Ohio 45238 |
Texoma Cancer Center | Wichita Falls, Texas 76310 |
The West Clinic | Memphis, Tennessee 38120 |
Northeast Georgia Cancer Care | Athens, Georgia 30607 |
Advanced Medical Specialties | Miami, Florida 33176 |
Hematology Oncology of Indiana | Indianapolis, Indiana 46260 |
Denver Health Medical Center CACZ885M2301 | Denver, Colorado 80204-4507 |
Northwest Cancer Specialists Vancouver Location | Portland, Oregon 97210 |
US Oncology Central Monitoring | Dallas, Texas 75246 |
Baylor College of Medicine Dept.of Baylor College of Med. | Houston, Texas 77030 |
Rocky Mountain Cancer Centers RMCC - Denver-Midtown | Greenwood Village, Colorado |
Georgia Health Sciences University Dept. of MCG | Augusta, Georgia 30912 |
Ironwood Cancer and Research Centers Ironwood | Chandler, Arizona 85224 |
Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
Sutter Health Cancer Research Group California Cancer Care | Greenbrae, California 94904 |
University of California San Diego Dept of Moores Cancer Ctr (3) | La Jolla, California 92093-0658 |
USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4) | Los Angeles, California 90033 |
Palo Alto Medical Foundation Hematology/Oncology | Mountain View, California 94040 |
California Pacific Medical Center Medical Research Institute | San Francisco, California 94120-7999 |
Redwood Regional Medical Group - Santa Rosa Dept. of RRMG (2) | Santa Rosa, California 94503 |
Stanford University Medical Center Dept. of Stanford University | Stanford, California 94304 |
Memorial Cancer Medicine Specialists | Colorado Springs, Colorado 80909 |
Hartford Hospital Cancer Clin Research Office | Hartford, Connecticut 06102 |
University Cancer Institute | Boyton Beach, Florida 33426 |
Cancer Centers of Florida PA Cancer Centers of FL-Ocoee (2) | Ocoee, Florida *see dep* |
Hematology Oncology Associates of Treasure Coast Hematology Onc of the Treasure | Port Lucie, Florida 34952 |
Columbus Regional | Columbus, Georgia 31904 |
Straub Clinic & Hospital Straub Clinic & Hospital (3) | Honolulu, Hawaii 96813 |
Northwestern University Northwest | Chicago, Illinois 60611 |
Rush University Medical Center Div. of Hematology & Oncology | Chicago, Illinois 60612 |
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola University (rm 101) | Maywood, Illinois 60153 |
Indiana University Health Goshen Center for Cancer IU Cancer Center | Indianapolis, Indiana 46202 |
University of Kansas Cancer Center Univ of Kansas (2) | Kansas City, Kansas 66160 |
Kentuckiana Cancer Institute Kentuckiana | Louisville, Kentucky 40202 |
Tulane University Health Sciences Center Office of Clinical Research | New Orleans, Louisiana 70112 |
Lahey Clinic Dept of Lahey Clinic (3) | Burlington, Massachusetts 01805 |
Mayo Clinic - Rochester Dept. of MayoClinic-Rochester | Rochester, Minnesota 55905 |
North Mississippi Hematology /Oncology MS Hem & Onc | Tupelo, Mississippi 38801 |
Washington University School Of Medicine-Siteman Cancer Ctr Div. of Medical Oncology | St. Louis, Missouri 63110 |
Nevada Cancer Institute Dept. of Nevada Cancer (3) | Las Vegas, Nevada 89135 |
Dartmouth Hitchcock Medical Center Dartmouth | Lebanon, New Hampshire 03756 |
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) | Morristown, New Jersey 07962 |
University of New Mexico Cancer Center CancerResearch & Treatment (2) | Albuquerque, New Mexico 87131 |
Arena Oncology Associates, PC Dept.ofArenaOncologyAssoc(2) | Lake Success, New York 11042 |
Cancer Care of Western North Carolina, PA | Asheville, North Carolina 28801 |
Levine Cancer Institute Oncology | Charlotte, North Carolina 28203 |
Wake Forest University Baptist Medical Center Dept. of WFUHS | Winston-Salem, North Carolina 27157 |
Zangmeister Center / Mid Ohio Oncology/Hematology Mid Ohio Onc Hem (2) | Columbus, Ohio 43219 |
Penn State University / Milton S. Hershey Medical Center Dept.ofMiltonS.HersheyMedCtr. | Hershey, Pennsylvania 17033-0850 |
Allegheny General Hospital Dept.ofAlleghenyCancerCtr (2) | Pittsburgh, Pennsylvania 15212 |
Medical University of South Carolina MUSC/HCC (2) | Charleston, South Carolina 29425 |
Cancer Centers of the Carolinas Cancer Centers of Carolinas (3 | Greenville, South Carolina 29605 |
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc | Mt. Pleasant, South Carolina 29464 |
University Oncology and Hematology Associates, PLLC | Chattanooga, Tennessee 37403 |
Family Cancer Center, PLC Family Cancer Center | Collierville, Tennessee 38017 |
University of Tennessee Cancer Institute SC-2 | Memphis, Tennessee 38104 |
Texas Oncology, P.A. Sammons Cancer Ctr. | Dallas, Texas 75251 |
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD | Fort Worth, Texas 76104 |
University of Texas, Houston Medical School UT Physicians Oncology | Houston, Texas 77030 |
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (18) | Houston, Texas 77030-4009 |
South Texas Oncology and Hematology, PA South Texas Oncology (2) | San Antonio, Texas 78258 |
Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care | Temple, Texas 76508 |
University of Vermont Office of Clinical Trials Res. | Burlington, Vermont 05404 |
Blue Ridge Research Center at Roanoke Neurological Center SC | Roanoke, Virginia 24014 |
Dean Health System | Madison, Wisconsin 53717 |
Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp. | Waukesha, Wisconsin 53188 |
St. Agnes Hospital SC | Baltimore, Maryland 21229 |
University of Pittsburgh Medical Center SC-3 | Pittsburgh, Pennsylvania |
University of Virginia Health Systems SC-2 | Charlottesville, Virginia 22908-0334 |