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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 (UNITY-NHL)

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ClinicalTrials.gov Identifier: NCT02793583
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Drug: TGR-1202 + Ublituximab Drug: TGR-1202 Drug: TGR-1202 + Ublituximab + Bendamustine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Experimental: TGR-1202 + Ublituximab
TGR-1202 oral daily dose in combination with Ublituximab intravenous administration
Drug: TGR-1202 + Ublituximab
Experimental: TGR-1202
TGR-1202 oral daily dose
Drug: TGR-1202
Other Name: Umbralisib

Experimental: TGR-1202 + Ublituximab + Bendamustine
TGR-1202 oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Drug: TGR-1202 + Ublituximab + Bendamustine
Other Name: Treanda




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Mantle Cell Lymphoma 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793583


Contacts
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Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com

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Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Birmingham, Alabama, United States, 35243
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site Recruiting
Chandler, Arizona, United States, 85224
TG Therapeutics Investigational Trial Site Recruiting
Tucson, Arizona, United States, 85711
TG Therapeutics Investigational Trial Site Recruiting
Tucson, Arizona, United States, 85724
United States, California
TG Therapeutics Investigational Trial Site Recruiting
Los Angeles, California, United States, 90095
TG Therapeutics Investigational Trial Site Completed
Orange, California, United States, 92868
TG Therapeutics Investigational Trial Site Recruiting
San Diego, California, United States, 92108
TG Therapeutics Investigational Trial Site Recruiting
Whittier, California, United States, 90603
United States, Colorado
TG Therapeutics Investigational Trial Site Recruiting
Boulder, Colorado, United States, 80012
TG Therapeutics Investigational Trial Site Recruiting
Denver, Colorado, United States, 80218
TG Therapeutics Investigational Trial Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Delaware
TG Therapeutics Investigational Trial Site Recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
TG Therapeutics Investigational Trial Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
TG Therapeutics Investigational Trial Site Recruiting
Boca Raton, Florida, United States, 33486
TG Therapeutics Investigational Trial Site Recruiting
Fort Myers, Florida, United States, 33916
TG Therapeutics Investigational Trial Site Recruiting
Gainesville, Florida, United States, 32608
TG Therapeutics Investigational Trial Site Recruiting
Jacksonville, Florida, United States, 32204
TG Therapeutics Investigational Trial Site Recruiting
Jacksonville, Florida, United States, 32224
TG Therapeutics Investigational Trial Site Completed
Jacksonville, Florida, United States, 32256
TG Therapeutics Investigational Trial Site Recruiting
Miami, Florida, United States, 33176
TG Therapeutics Investigational Trial Site Recruiting
Saint Petersburg, Florida, United States, 33705
TG Therapeutics Investigational Trial Site Recruiting
Tallahassee, Florida, United States, 32308
TG Therapeutics Investigational Trial Site Recruiting
Tampa, Florida, United States, 33612
TG Therapeutics Investigational Trial Site Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
TG Therapeutics Investigational Trial Site Completed
Albany, Georgia, United States, 31701
TG Therapeutics Investigational Trial Site Recruiting
Macon, Georgia, United States, 31201
United States, Illinois
TG Therapeutics Investigational Trial Site Recruiting
Chicago, Illinois, United States, 60612
TG Therapeutics Investigational Trial Site Recruiting
Chicago, Illinois, United States, 60637
TG Therapeutics Investigational Trial Site Recruiting
Decatur, Illinois, United States, 62526
TG Therapeutics Investigational Trial Site Recruiting
Evanston, Illinois, United States, 60201
TG Therapeutics Investigational Trial Site Recruiting
Harvey, Illinois, United States, 60426
TG Therapeutics Investigational Trial Site Recruiting
Maywood, Illinois, United States, 60153
TG Therapeutics Investigational Trial Site Recruiting
Niles, Illinois, United States, 60714
TG Therapeutics Investigational Trial Site Recruiting
Peoria, Illinois, United States, 61615
TG Therapeutics Investigational Trial Site Recruiting
Swansea, Illinois, United States, 62226
United States, Indiana
TG Therapeutics Investigational Trial Site Recruiting
Fort Wayne, Indiana, United States, 46845
TG Therapeutics Investigational Trial Site Recruiting
Indianapolis, Indiana, United States, 46237
United States, Kansas
TG Therapeutics Investigational Trial Site Recruiting
Westwood, Kansas, United States, 66210
United States, Kentucky
TG Therapeutics Investigational Trial Site Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
TG Therapeutics Investigational Trial Site Recruiting
Covington, Louisiana, United States, 70433
United States, Maine
TG Therapeutics Investigational Trial Site Recruiting
Brewer, Maine, United States, 04412
United States, Maryland
TG Therapeutics Investigational Trial Site Recruiting
Baltimore, Maryland, United States, 21201
TG Therapeutics Investigational Trial Site Recruiting
Bethesda, Maryland, United States, 20817
TG Therapeutics Investigational Trial Site Recruiting
Columbia, Maryland, United States, 21044
TG Therapeutics Investigational Trial Site Recruiting
Towson, Maryland, United States, 21204
United States, Michigan
TG Therapeutics Investigational Trial Site Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
TG Therapeutics Investigational Trial Site Recruiting
Duluth, Minnesota, United States, 55805
TG Therapeutics Investigational Trial Site Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
TG Therapeutics Investigational Trial Site Recruiting
Columbia, Missouri, United States, 65212
TG Therapeutics Investigational Trial Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Montana
TG Therapeutics Investigational Trial Site Recruiting
Billings, Montana, United States, 59102
United States, Nebraska
TG Therapeutics Investigational Trial Site Completed
Lincoln, Nebraska, United States, 68510
TG Therapeutics Investigational Trial Site Recruiting
Omaha, Nebraska, United States, 68130
United States, New Hampshire
TG Therapeutics Investigational Trial Site Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
TG Therapeutics Investigational Trial Site Recruiting
Hackensack, New Jersey, United States, 07601
TG Therapeutics Investigational Trial Site Recruiting
Morristown, New Jersey, United States, 07962
TG Therapeutics Investigational Trial Site Completed
Mount Holly, New Jersey, United States, 08060
United States, New Mexico
TG Therapeutics Investigational Trial Site Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
TG Therapeutics Investigational Trial Site Completed
Bronx, New York, United States, 10467
TG Therapeutics Investigational Trial Site Recruiting
Buffalo, New York, United States, 14263
TG Therapeutics Investigational Trial Site Recruiting
New York, New York, United States, 10019
TG Therapeutics Investigational Trial Site Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
TG Therapeutics Investigational Trial Site Recruiting
Charlotte, North Carolina, United States, 28201
TG Therapeutics Investigational Trial Site Recruiting
Durham, North Carolina, United States, 27705
TG Therapeutics Investigational Trial Site Completed
Hickory, North Carolina, United States, 28602
TG Therapeutics Investigational Trial Site Recruiting
Kinston, North Carolina, United States, 28501
TG Therapeutics Investigational Trial Site Recruiting
Raleigh, North Carolina, United States, 27607
TG Therapeutics Investigational Trial Site Recruiting
Washington, North Carolina, United States, 27889
United States, Ohio
TG Therapeutics Investigational Trial Site Recruiting
Canton, Ohio, United States, 44718
TG Therapeutics Investigational Trial Site Completed
Cincinnati, Ohio, United States, 45220
TG Therapeutics Investigational Trial Site Recruiting
Cincinnati, Ohio, United States, 45236
TG Therapeutics Investigational Trial Site Recruiting
Cleveland, Ohio, United States, 44106
TG Therapeutics Investigational Trial Site Recruiting
Columbus, Ohio, United States, 43219
TG Therapeutics Investigational Trial Site Recruiting
Toledo, Ohio, United States, 43623
United States, Oregon
TG Therapeutics Investigational Trial Site Recruiting
Portland, Oregon, United States, 97213
TG Therapeutics Investigational Trial Site Recruiting
Portland, Oregon, United States, 97227
TG Therapeutics Investigational Trial Site Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
TG Therapeutics Investigational Trial Site Recruiting
Camp Hill, Pennsylvania, United States, 17011
TG Therapeutics Investigational Trial Site Recruiting
Philadelphia, Pennsylvania, United States, 19106
United States, Rhode Island
TG Therapeutics Investigational Trial Site Recruiting
Providence, Rhode Island, United States, 02906
United States, South Carolina
TG Therapeutics Investigational Trial Site Recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
TG Therapeutics Investigational Trial Site Recruiting
Sioux Falls, South Dakota, United States, 57105
TG Therapeutics Investigational Trial Site Recruiting
Watertown, South Dakota, United States, 57201
United States, Tennessee
TG Therapeutics Investigational Trial Site Recruiting
Chattanooga, Tennessee, United States, 37404
TG Therapeutics Investigational Trial Site Completed
Kingsport, Tennessee, United States, 37660
TG Therapeutics Investigational Trial Site Recruiting
Knoxville, Tennessee, United States, 37916
TG Therapeutics Investigational Trial Site Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
TG Therapeutics Investigational Trial Site Recruiting
Austin, Texas, United States, 78705
TG Therapeutics Investigational Trial Site Recruiting
Dallas, Texas, United States, 75390
TG Therapeutics Investigational Trial Site Recruiting
Fort Sam Houston, Texas, United States, 78234
TG Therapeutics Investigational Trial Site Recruiting
Houston, Texas, United States, 77030
TG Therapeutics Investigational Trial Site Recruiting
San Antonio, Texas, United States, 78130
TG Therapeutics Investigational Trial Site Recruiting
San Antonio, Texas, United States, 78217
TG Therapeutics Investigational Trial Site Completed
San Antonio, Texas, United States, 78229
TG Therapeutics Investigational Trial Site Recruiting
Tyler, Texas, United States, 75702
United States, Utah
TG Therapeutics Investigational Trial Site Recruiting
Ogden, Utah, United States, 84403
United States, Virginia
TG Therapeutics Investigational Trial Site Recruiting
Blacksburg, Virginia, United States, 24060
TG Therapeutics Investigational Trial Site Recruiting
Newport News, Virginia, United States, 23601
United States, Washington
TG Therapeutics Investigational Trial Site Completed
Olympia, Washington, United States, 98502
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98104
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98108
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98109
TG Therapeutics Investigational Trial Site Recruiting
Spokane, Washington, United States, 99216
TG Therapeutics Investigational Trial Site Recruiting
Vancouver, Washington, United States, 97277
United States, Wisconsin
TG Therapeutics Investigational Trial Site Recruiting
Madison, Wisconsin, United States, 53792
TG Therapeutics Investigational Trial Site Recruiting
Wauwatosa, Wisconsin, United States, 53226
Australia
TG Therapeutics Investigational Trial Site Recruiting
Benowa, Australia
TG Therapeutics Investigational Trial Site Recruiting
Gosford, Australia
TG Therapeutics Investigational Trial Site Recruiting
Heidelberg, Australia
TG Therapeutics Investigational Trial Site Recruiting
Nedlands, Australia
TG Therapeutics Investigational Trial Site Recruiting
Netherlands, Australia
TG Therapeutics Investigational Trial Site Recruiting
South Brisbane, Australia
Israel
TG Therapeutics Investigational Trial Site Recruiting
Ashkelon, Israel
TG Therapeutics Investigational Trial Site Recruiting
Be'er Sheva, Israel
TG Therapeutics Investigational Trial Site Recruiting
Haifa, Israel
TG Therapeutics Investigational Trial Site Recruiting
Jerusalem, Israel
TG Therapeutics Investigational Trial Site Recruiting
Nahariya, Israel
TG Therapeutics Investigational Trial Site Recruiting
Tel Aviv, Israel
Italy
TG Therapeutics Investigational Trial Site Recruiting
Bologna, Italy
TG Therapeutics Investigational Trial Site Recruiting
Ferrara, Italy
TG Therapeutics Investigational Trial Site Recruiting
Milan, Italy
TG Therapeutics Investigational Trial Site Recruiting
Rome, Italy
TG Therapeutics Investigational Trial Site Recruiting
Torino, Italy
Korea, Republic of
TG Therapeutics Investigational Trial Site Recruiting
Busan, Korea, Republic of
TG Therapeutics Investigational Trial Site Recruiting
Gyeonggi-do, Korea, Republic of
TG Therapeutics Investigational Trial Site Recruiting
Incheon, Korea, Republic of
TG Therapeutics Investigational Trial Site Recruiting
Seoul, Korea, Republic of
Poland
TG Therapeutics Investigational Trial Site Recruiting
Chorzów, Poland
TG Therapeutics Investigational Trial Site Recruiting
Gdynia, Poland
TG Therapeutics Investigational Trial Site Recruiting
Kraków, Poland
TG Therapeutics Investigational Trial Site Recruiting
Lublin, Poland
TG Therapeutics Investigational Trial Site Recruiting
Słupsk, Poland
TG Therapeutics Investigational Trial Site Recruiting
Warszawa, Poland
TG Therapeutics Investigational Trial Site Recruiting
Wrocław, Poland
TG Therapeutics Investigational Trial Site Recruiting
Łódź, Poland
Slovakia
TG Therapeutics Investigational Trial Site Recruiting
Bratislava, Slovakia
TG Therapeutics Investigational Trial Site Completed
Košice, Slovakia
TG Therapeutics Investigational Trial Site Recruiting
Poprad, Slovakia
Spain
TG Therapeutics Investigational Trial Site Recruiting
Barcelona, Spain
TG Therapeutics Investigational Trial Site Recruiting
Madrid, Spain
TG Therapeutics Investigational Trial Site Recruiting
Salisbury, Spain
TG Therapeutics Investigational Trial Site Recruiting
Valencia, Spain
United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Cambridge, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Denmark Hill, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Leeds, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Liverpool, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
London, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Oxford, United Kingdom
TG Therapeutics Investigational Trial Site Recruiting
Plymouth, United Kingdom
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Owen A O'Connor, MD, PhD Columbia University

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02793583     History of Changes
Other Study ID Numbers: UTX-TGR-205
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared once the last patient visit has been completed
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs