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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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
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Sioux Falls, South Dakota 57105
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Adelaide,
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Ann Arbor, Michigan 48106
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Baltimore, Maryland 21215
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Birmingham, Alabama 35213
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Boca Raton, Florida 33486
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Camp Hill, Pennsylvania 17011
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Canton, OH
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Cary, North Carolina 27518
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Chandler, AZ
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37404
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Chicago, IL
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Costa Mesa, California 92627
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Covington, Louisiana 70433
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Durham, North Carolina 27710
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Edmonds, Washington 98026
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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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Fort Wayne, Indiana 46804
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Gainesville, Florida 32605
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Green Bay, Wisconsin 54311
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Greenville, South Carolina 29615
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Hackensack, New Jersey 07601
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Hickory, North Carolina 28602
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Huntsville, Alabama 35805
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Indianapolis, Indiana 46237
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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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Knoxville, Tennessee 37922
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Lebanon, New Hampshire 03756
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Los Angeles, California 90045
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Louisville, Kentucky 40207
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Middleburg Heights, Ohio 44130
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Morristown, New Jersey 07962
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Mount Holly, New Jersey 08060
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New Braunfels, Texas 78130
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Providence, Rhode Island 02906
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Raleigh, North Carolina 27607
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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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San Diego, California 92093
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Seattle, Washington 98104
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Spokane, Washington 99216
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Springfield, Oregon 97477
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Tallahassee, Florida 32308
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Vancouver, Washington 98684
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Washington, District of Columbia 20007
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