Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:June 2016
End Date:July 2019
Contact:TG Therapeutics Clinical Support Team
Email:clinicalsupport@tgtxinc.com
Phone:212-554-4279

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in
combination with another study drug called ublituximab with or without bendamustine and
TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or
that has not responded to standard treatment.


Inclusion Criteria:

- Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma,
Follicular, Small Lymphocytic and Marginal Zone Lymphoma

- Relapsed or refractory to prior standard therapy and subjects who are not candidates
for high-dose therapy or autologous stem cell transplant

- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

- Any major surgery, chemotherapy or immunotherapy within the last 21 days

- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection

- Autologous hematologic stem cell transplant within 6 months of study entry. Prior
Allogeneic hematologic stem cell transplant is excluded

- Prior therapy with a PI3K delta inhibitor
We found this trial at
106
sites
TG Therapeutics Investigational Trial Site
Omaha, Nebraska 68198
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Adelaide,
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Ann Arbor, Michigan 48106
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Ann Arbor, MI
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TG Therapeutics Investigational Trial Site
Austin, Texas 78705
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Austin, TX
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TG Therapeutics Investigational Trial Site
Baltimore, Maryland 21215
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Baltimore, MD
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TG Therapeutics Investigational Trial Site
Bethesda, Maryland 20817
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TG Therapeutics Investigational Trial Site
Billings, Montana 59102
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TG Therapeutics Trial Site
Birmingham, Alabama 35213
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Birmingham, AL
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TG Therapeutics Investigational Trial Site
Boca Raton, Florida 33486
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TG Therapeutics Investigational Trial Site
Boulder, Colorado 80303
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Boulder, CO
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TG Therapeutics Investigational Trial Site
Brewer, Maine 04412
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Brewer, ME
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TG Therapeutics Investigational Trial Site
Bronx, New York 10467
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Bronx, NY
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TG Therapeutics Investigational Trial Site
Buffalo, New York 14263
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Buffalo, NY
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TG Therapeutics Investigational Trial Site
Camp Hill, Pennsylvania 17011
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Camp Hill, PA
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TG Therapeutics Investigational Trial Site
Canton, Ohio 44718
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Canton, OH
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TG Therapeutics Investigational Trial Site
Cary, North Carolina 27518
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Cary, NC
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TG Therapeutics Investigational Trial Site
Chandler, Arizona 85224
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Chandler, AZ
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TG Therapeutics Investigational Trial Site
Charlotte, North Carolina 28204
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Charlotte, NC
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TG Therapeutics Investigational Trial Site
Chattanooga, Tennessee 37404
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TG Therapeutics Investigational Trial Site
Chicago, Illinois 60612
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Chicago, IL
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TG Therapeutics Investigational Trial Site
Cincinnati, Ohio 45242
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Cincinnati, OH
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TG Therapeutics Investigational Trial Site
Cleveland, Ohio 44106
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Cleveland, OH
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TG Therapeutics Investigational Trial Site
Columbia, Maryland 21044
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Columbia, MD
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TG Therapeutics Investigational Trial Site
Columbia, Missouri 65212
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Columbia, MO
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TG Therapeutics Investigational Trial Site
Columbus, Ohio 43201
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Columbus, OH
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Costa Mesa, California 92627
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Costa Mesa, CA
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TG Therapeutics Investigational Trial Site
Covington, Louisiana 70433
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Covington, LA
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TG Therapeutics Investigational Trial Site
Dallas, Texas 75230
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Dallas, TX
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TG Therapeutics Investigational Trial Site
Decatur, Illinois 62526
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Decatur, IL
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TG Therapeutics Investigational Trial Site
Denver, Colorado 80220
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Denver, CO
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TG Therapeutics Investigational Trial Site
Duluth, Minnesota 55805
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Duluth, MN
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TG Therapeutics Trial Site
Durham, North Carolina 27710
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Durham, NC
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TG Therapeutics Investigational Trial Site
Edmonds, Washington 98026
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Edmonds, WA
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TG Therapeutics Investigational Trial Site
Elyria, Ohio 44035
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Elyria, OH
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TG Therapeutics Investigational Trial Site
Evanston, Illinois 60201
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Evanston, IL
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TG Therapeutics Investigational Trial Site
Fairway, Kansas 66205
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Fairway, KS
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Farmington, New Mexico 87401
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Fort Collins, Colorado 80528
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Fort Myers, Florida 33905
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TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana 46804
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Fort Wayne, IN
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TG Therapeutics Investigational Trial Site
Gainesville, Florida 32605
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Gainesville, FL
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TG Therapeutics Investigational Trial Site
Green Bay, Wisconsin 54311
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Green Bay, WI
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Greenville, South Carolina 29615
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Greenville, SC
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TG Therapeutics Trial Site
Hackensack, New Jersey 07601
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Hackensack, NJ
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Hammond, Louisiana 70403
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TG Therapeutics Investigational Trial Site
Harvey, Illinois 60426
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Harvey, IL
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Hickory, North Carolina 28602
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Houston, Texas 77030
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Houston, TX
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Huntsville, Alabama 35805
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Indianapolis, Indiana 46237
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Indianapolis, IN
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Jacksonville, Florida 32204
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Kansas City, Kansas 64132
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Kingsport, Tennessee 37660
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Kinston, North Carolina 28501
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Kinston, NC
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Knoxville, Tennessee 37922
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Lebanon, New Hampshire 03756
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TG Therapeutics Investigational Trial Site
Lincoln, Nebraska 68510
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Los Angeles, California 90045
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Los Angeles, CA
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Louisville, Kentucky 40207
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Macon, Georgia 31201
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Macon, GA
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Madison, Wisconsin 53792
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Marietta, Georgia 30060
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Maywood, Illinois 60153
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Memphis, Tennessee 38120
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TG Therapeutics Investigational Trial Site
Mentor, Ohio 44060
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Miami, Florida 33176
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Miami, FL
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Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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Morristown, New Jersey 07962
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TG Therapeutics Investigational Trial Site
Mount Holly, New Jersey 08060
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New Braunfels, Texas 78130
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New York, New York 10022
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Newark, Delaware 19173
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Newport News, Virginia 23601
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Niles, Illinois 60714
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Ogden, Utah 84405
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Orange, California 09286
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Peoria, Illinois 61615
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Portland, Oregon 97213
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Portland, OR
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Providence, Rhode Island 02906
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Providence, RI
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Raleigh, North Carolina 27607
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Raleigh, NC
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Roanoke, Virginia 24014
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Roanoke, VA
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Saint Louis, Missouri 63110
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Saint Louis Park, Minnesota 55416
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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San Antonio, Texas 78229
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San Diego, California 92093
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Sandusky, Ohio 44870
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Seattle, Washington 98104
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Sioux Falls, South Dakota 57105
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Spokane, Washington 99216
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Springfield, Oregon 97477
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Swansea, Illinois 62226
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Syracuse, New York 13210
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Tallahassee, Florida 32308
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Tampa, Florida 33607
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Toledo, Ohio 43623
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Towson, Maryland 21204
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Tucson, Arizona 85710
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Tyler, Texas 75702
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Vancouver, Washington 98684
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TG Therapeutics Investigational Trial Site
Washington, District of Columbia 20007
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