Trial record 1 of 1 for:
UNITY-CLL
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02612311 |
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Recruitment Status :
Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : March 20, 2023
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Sponsor:
TG Therapeutics, Inc.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
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Brief Summary:
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia | Biological: Obinutuzumab Biological: Ublituximab Drug: TGR-1202 Drug: Chlorambucil | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL) |
| Actual Study Start Date : | November 19, 2015 |
| Estimated Primary Completion Date : | November 1, 2023 |
| Estimated Study Completion Date : | January 1, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
Experimental: Ublituximab + TGR-1202
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Biological: Ublituximab
Ublituximab: IV infusion Drug: TGR-1202 TGR-1202: Oral daily dose |
Active Comparator: Obinutuzumab + Chlorambucil
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Biological: Obinutuzumab
Obinutuzumab: IV infusion
Other Name: GAZYVA Drug: Chlorambucil Chlorambucil: Oral dose
Other Name: Leukeran |
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Experimental: Ublituximab
- Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
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Biological: Ublituximab
Ublituximab: IV infusion |
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Experimental: TGR-1202
- TGR-1202: Fixed oral daily dose
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Drug: TGR-1202
TGR-1202: Oral daily dose |
Primary Outcome Measures :
- Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 3 years ]To assess the progression-free survival (PFS) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with TGR-1202 compared to obinutuzumab + chlorambucil
Secondary Outcome Measures :
- Overall Response Rate [ Time Frame: Every 12 weeks up to 2 years ]To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202 compared to ublituximab and TGR-1202 alone
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:
- Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
- 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 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
- Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
- Prior therapy with obinutuzumab and/or chlorambucil or 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): NCT02612311
Locations
Hide 154 study locations
| United States, Alabama | |
| TG Therapeutics Investigational Trial Site | |
| Huntsville, Alabama, United States, 35805 | |
| TG Therapeutics Investigational Trial Site | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| TG Therapeutics Investigational Trial Site | |
| Chandler, Arizona, United States, 85224 | |
| TG Therapeutics Investigational Trial Site | |
| Phoenix, Arizona, United States, 85016 | |
| TG Therapeutics Investigational Trial Site | |
| Tucson, Arizona, United States, 85711 | |
| United States, Arkansas | |
| TG Therapeutics Investigational Trial Site | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| TG Therapeutics Investigational Trial Site | |
| Concord, California, United States, 94520 | |
| TG Therapeutics Investigational Trial Site | |
| Duarte, California, United States, 91010 | |
| TG Therapeutics Investigational Trial Site | |
| Greenbrae, California, United States, 94904 | |
| TG Therapeutics Investigational Trial Site | |
| Pismo Beach, California, United States, 93449 | |
| TG Therapeutics Investigational Trial Site | |
| Pleasanton, California, United States, 94588 | |
| TG Therapeutics Investigational Trial Site | |
| San Diego, California, United States, 92120 | |
| TG Therapeutics Investigational Trial Site | |
| Santa Barbara, California, United States, 93105 | |
| TG Therapeutics Investigational Trial Site | |
| Whittier, California, United States, 90603 | |
| United States, Colorado | |
| TG Therapeutics Investigational Trial Site | |
| Aurora, Colorado, United States, 80012 | |
| TG Therapeutics Investigational Trial Site | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| TG Therapeutics Investigational Trial Site | |
| Bridgeport, Connecticut, United States, 06606 | |
| TG Therapeutics Investigational Trial Site | |
| New Haven, Connecticut, United States, 06519 | |
| TG Therapeutics Investigational Trial Site | |
| Stamford, Connecticut, United States, 06904 | |
| United States, Delaware | |
| TG Therapeutics Investigational Trial Site | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| TG Therapeutics Investigational Trial Site | |
| Boca Raton, Florida, United States, 33486 | |
| TG Therapeutics Investigational Trial Site | |
| Fort Myers, Florida, United States, 33916 | |
| TG Therapeutics Investigational Trial Site | |
| Jacksonville, Florida, United States, 32204 | |
| TG Therapeutics Investigational Trial Site | |
| Jacksonville, Florida, United States, 32256 | |
| TG Therapeutics Investigational Trial Site | |
| Ocala, Florida, United States, 34471 | |
| TG Therapeutics Investigational Trial Site | |
| Pensacola, Florida, United States, 32504 | |
| TG Therapeutics Investigational Trial Site | |
| Saint Petersburg, Florida, United States, 33705 | |
| TG Therapeutics Investigational Trial Site | |
| Tallahassee, Florida, United States, 32308 | |
| TG Therapeutics Investigational Trial Site | |
| Tampa, Florida, United States, 33612 | |
| TG Therapeutics Investigational Trial Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| TG Therapeutics Investigational Trial Site | |
| Albany, Georgia, United States, 31701 | |
| TG Therapeutics Investigational Trial Site | |
| Macon, Georgia, United States, 31201 | |
| United States, Illinois | |
| TG Therapeutics Investigational Trial Site | |
| Chicago, Illinois, United States, 60612 | |
| TG Therapeutics Investigational Trial Site | |
| Decatur, Illinois, United States, 62526 | |
| TG Therapeutics Investigational Trial Site | |
| Maywood, Illinois, United States, 60153 | |
| TG Therapeutics Investigational Trial Site | |
| Niles, Illinois, United States, 60714 | |
| TG Therapeutics Investigational Trial Site | |
| Peoria, Illinois, United States, 61615 | |
| TG Therapeutics Investigational Trial Site | |
| Swansea, Illinois, United States | |
| TG Therapeutics Investigational Trial Site | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| TG Therapeutics Investigational Trial Site | |
| Fort Wayne, Indiana, United States, 46804 | |
| TG Therapeutics Investigational Trial Site | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Iowa | |
| TG Therapeutics Investigational Trial Site | |
| Ames, Iowa, United States, 50010 | |
| TG Therapeutics Investigational Trial Site | |
| Cedar Rapids, Iowa, United States, 52403 | |
| United States, Kansas | |
| TG Therapeutics Investigational Trial Site | |
| Kansas City, Kansas, United States, 64132 | |
| TG Therapeutics Investigational Trial Site | |
| Westwood, Kansas, United States, 66210 | |
| United States, Kentucky | |
| TG Therapeutics Investigational Trial Site | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| TG Therapeutics Investigational Trial Site | |
| Baltimore, Maryland, United States, 21202 | |
| TG Therapeutics Investigational Trial Site | |
| Baltimore, Maryland, United States, 21215 | |
| TG Therapeutics Investigational Trial Site | |
| Bethesda, Maryland, United States, 20817 | |
| TG Therapeutics Investigational Trial Site | |
| Columbia, Maryland, United States, 21044 | |
| United States, Massachusetts | |
| TG Therapeutics Investigational Trial Site | |
| Boston, Massachusetts, United States, 02111 | |
| TG Therapeutics Investigational Trial Site | |
| Worcester, Massachusetts, United States, 01608 | |
| United States, Michigan | |
| TG Therapeutics Investigational Trial Site | |
| Ann Arbor, Michigan, United States, 48106 | |
| TG Therapeutics Investigational Trial Site | |
| Detroit, Michigan, United States, 48202 | |
| TG Therapeutics Investigational Trial Site | |
| Jackson, Michigan, United States, 49201 | |
| United States, Minnesota | |
| TG Therapeutics Investigational Trial Site | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| TG Therapeutics Investigational Trial Site | |
| Columbia, Missouri, United States, 65212 | |
| TG Therapeutics Investigational Trial Site | |
| Kansas City, Missouri, United States | |
| United States, Nebraska | |
| TG Therapeutics Investigational Trial Site | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| TG Therapeutics Investigational Trial Site | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Hampshire | |
| TG Therapeutics Investigational Trial Site | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| TG Therapeutics Investigational Trial Site | |
| Morristown, New Jersey, United States, 07962 | |
| TG Therapeutics Investigational Trial Site | |
| Somerville, New Jersey, United States, 00876 | |
| United States, New York | |
| TG Therapeutics Investigational Trial Site | |
| East Setauket, New York, United States, 11733 | |
| TG Therapeutics Investigational Trial Site | |
| Glens Falls, New York, United States, 12801 | |
| TG Therapeutics Investigational Trial Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| TG Therapeutics Investigational Trial Site | |
| Charlotte, North Carolina, United States, 28204 | |
| TG Therapeutics Investigational Trial Site | |
| Durham, North Carolina, United States, 27710 | |
| TG Therapeutics Investigational Trial Site | |
| Durham, North Carolina, United States | |
| TG Therapeutics Investigational Trial Site | |
| Hickory, North Carolina, United States, 28602 | |
| TG Therapeutics Investigational Trial Site | |
| Kinston, North Carolina, United States, 28501 | |
| TG Therapeutics Investigational Trial Site | |
| Raleigh, North Carolina, United States, 27607 | |
| TG Therapeutics Investigational Trial Site | |
| Washington, North Carolina, United States, 27889 | |
| United States, Ohio | |
| TG Therapeutics Investigational Trial Site | |
| Canton, Ohio, United States, 44718 | |
| TG Therapeutics Investigational Trial Site | |
| Cincinnati, Ohio, United States, 45236 | |
| TG Therapeutics Investigational Trial Site | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oregon | |
| TG Therapeutics Investigational Trial Site | |
| Portland, Oregon, United States, 97227 | |
| TG Therapeutics Investigational Trial Site | |
| Portland, Oregon, United States, 97239 | |
| TG Therapeutics Investigational Trial Site | |
| Springfield, Oregon, United States, 97477 | |
| United States, Pennsylvania | |
| TG Therapeutics Investigational Trial Site | |
| Camp Hill, Pennsylvania, United States, 17011 | |
| TG Therapeutics Investigational Trial Site | |
| Danville, Pennsylvania, United States, 17822 | |
| TG Therapeutics Investigational Trial Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| TG Therapeutics Investigational Trial Site | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| TG Therapeutics Investigational Trial Site | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| TG Therapeutics Investigational Trial Site | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Rhode Island | |
| TG Therapeutics Investigational Trial Site | |
| Pawtucket, Rhode Island, United States, 00286 | |
| United States, South Carolina | |
| TG Therapeutics Investigational Trial Site | |
| Greenville, South Carolina, United States, 29615 | |
| United States, South Dakota | |
| TG Therapeutics Investigational Trial Site | |
| Sioux Falls, South Dakota, United States, 57105 | |
| TG Therapeutics Investigational Trial Site | |
| Watertown, South Dakota, United States, 57201 | |
| United States, Tennessee | |
| TG Therapeutics Investigational Trial Site | |
| Chattanooga, Tennessee, United States, 37404 | |
| TG Therapeutics Investigational Trial Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| TG Therapeutics Investigational Trial Site | |
| Austin, Texas, United States, 78705 | |
| TG Therapeutics Investigational Trial Site | |
| Bedford, Texas, United States, 76022 | |
| TG Therapeutics Investigational Trial Site | |
| Fort Worth, Texas, United States, 76104 | |
| TG Therapeutics Investigational Trial Site | |
| Houston, Texas, United States, 77030 | |
| TG Therapeutics Investigational Trial Site | |
| San Antonio, Texas, United States, 78217 | |
| TG Therapeutics Investigational Trial Site | |
| San Antonio, Texas, United States, 78229 | |
| TG Therapeutics Investigational Trial Site | |
| Tyler, Texas, United States, 75702 | |
| United States, Utah | |
| TG Therapeutics Investigational Trial Site | |
| Ogden, Utah, United States, 84405 | |
| United States, Virginia | |
| TG Therapeutics Investigational Trial Site | |
| Blacksburg, Virginia, United States, 24060 | |
| TG Therapeutics Investigational Trial Site | |
| Charlottesville, Virginia, United States, 22908 | |
| TG Therapeutics Investigational Trial Site | |
| Fort Belvoir, Virginia, United States, 22060 | |
| United States, Washington | |
| TG Therapeutics Investigational Trial Site | |
| Olympia, Washington, United States, 98502 | |
| TG Therapeutics Investigational Trial Site | |
| Seattle, Washington, United States, 98104 | |
| TG Therapeutics Investigational Trial Site | |
| Seattle, Washington, United States, 98109 | |
| TG Therapeutics Investigational Trial Site | |
| Spokane, Washington, United States, 99216 | |
| TG Therapeutics Investigational Trial Site | |
| Vancouver, Washington, United States, 98684 | |
| TG Therapeutics Investigational Trial Site | |
| Yakima, Washington, United States, 98902 | |
| United States, Wisconsin | |
| TG Therapeutics Investigational Trial Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| TG Therapeutics Investigational Trial Site | |
| Wauwatosa, Wisconsin, United States, 53226 | |
| Israel | |
| TG Therapeutics Investigational Trial Site | |
| Ashkelon, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Be'er Sheva, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Haifa, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Jerusalem, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Nahariya, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Petah tikva, Israel | |
| TG Therapeutics Investigational Trial Site | |
| Tel Aviv, Israel | |
| Italy | |
| TG Therapeutics Investigational Trial Site | |
| Bologna, Italy | |
| TG Therapeutics Investigational Trial Site | |
| Ferrara, Italy | |
| TG Therapeutics Investigational Trial Site | |
| Milan, Italy | |
| TG Therapeutics Investigational Trial Site | |
| Rome, Italy | |
| TG Therapeutics Investigational Trial Site | |
| Torino, Italy | |
| Poland | |
| TG Therapeutics Investigational Trial Site | |
| Chorzów, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Gdynia, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Krakow, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Lublin, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Słupsk, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Warszawa, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Wroclaw, Poland | |
| TG Therapeutics Investigational Trial Site | |
| Łódź, Poland | |
| Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Krasnozatonskiy, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Moscow, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Perm, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Petrozavodsk, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Rodionova, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Saint Petersburg, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Smolensk, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Tula, Russian Federation | |
| TG Therapeutics Investigational Trial Site | |
| Yaroslavl, Russian Federation | |
| Spain | |
| TG Therapeutics Investigational Trial Site | |
| Barcelona, Spain | |
| TG Therapeutics Investigational Trial Site | |
| Madrid, Spain | |
| TG Therapeutics Investigational Trial Site | |
| Valencia, Spain | |
| United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Cambridge, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Cumbria, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Dudley West, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| London, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Northbrook, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Northumbria, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Norwich, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Peterborough, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Southampton, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| St. James, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Sunderland, United Kingdom | |
| TG Therapeutics Investigational Trial Site | |
| Wolverhampton, United Kingdom | |
Sponsors and Collaborators
TG Therapeutics, Inc.
| Responsible Party: | TG Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02612311 |
| Other Study ID Numbers: |
UTX-TGR-304 |
| First Posted: | November 23, 2015 Key Record Dates |
| Last Update Posted: | March 20, 2023 |
| Last Verified: | March 2023 |
Additional relevant MeSH terms:
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Leukemia, B-Cell Obinutuzumab Chlorambucil Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |