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An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

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: NCT02656303
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2016
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Biological: ublituximab Drug: TGR-1202 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
Actual Study Start Date : January 7, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Ublituximab + TGR-1202
Ublituximab IV treatment + TGR-1202 oral daily dose
Biological: ublituximab
ublituximab IV infusion
Other Name: TG-1101

Drug: TGR-1202
TGR-1202 oral daily dose




Primary Outcome Measures :
  1. 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



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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:

  • Prior treatment in clinical trial UTX-TGR-304
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Patients refractory to ublituximab + TGR-1202
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)

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): NCT02656303


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Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site
Chandler, Arizona, United States, 85224
United States, Arkansas
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States, 72703
United States, California
TG Therapeutics Investigational Trial Site
Duarte, California, United States, 91010
TG Therapeutics Investigational Trial Site
Pleasanton, California, United States, 94588
TG Therapeutics Investigational Trial Site
San Diego, California, United States, 92108
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
Saint Petersburg, Florida, United States, 33705
TG Therapeutics Investigational Trial Site
Tallahassee, Florida, United States, 32308
TG Therapeutics Investigational Trial Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
TG Therapeutics Investigational Trial Site
Albany, Georgia, United States, 31701
United States, Illinois
TG Therapeutics Investigational Trial Site
Decatur, Illinois, United States, 62526
TG Therapeutics Investigational Trial Site
Peoria, Illinois, United States, 61615
TG Therapeutics Investigational Trial Site
Urbana, Illinois, United States, 60612
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, Kansas
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, Massachusetts
TG Therapeutics Investigational Trial Site
Worcester, Massachusetts, United States, 01608
United States, Michigan
TG Therapeutics Investigational Trial Site
Ann Arbor, Michigan, United States, 48197
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
Kansas City, Missouri, United States, 64132
United States, Nebraska
TG Therapeutics Investigational Trial Site
Lincoln, Nebraska, United States, 68510
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, 07932
United States, New York
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
Hickory, North Carolina, United States, 28602
TG Therapeutics Investigational Trial Site
Kinston, North Carolina, United States, 28501
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
Toledo, Ohio, United States, 43623
United States, Oregon
TG Therapeutics Investigational Trial Site
Portland, Oregon, United States, 98684
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
Hershey, Pennsylvania, United States, 17033
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, United States, 19106
United States, Rhode Island
TG Therapeutics Investigational Trial Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States, 29605
United States, South Dakota
TG Therapeutics Investigational Trial Site
Sioux Falls, South Dakota, United States, 57105
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
San Antonio, Texas, United States, 78240
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
United States, Washington
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States, 98109
TG Therapeutics Investigational Trial Site
Spokane, Washington, United States, 99216
United States, Wisconsin
TG Therapeutics Investigational Trial Site
Wauwatosa, Wisconsin, United States, 53226
Italy
TG Therapeutics Investigational Trial Site
Ferrara, Italy
TG Therapeutics Investigational Trial Site
Milan, 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
Kraków, 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
Łódź, Poland
United Kingdom
TG Therapeutics Investigational Trial Site
Norwich, United Kingdom
TG Therapeutics Investigational Trial Site
Wolverhampton, United Kingdom
Sponsors and Collaborators
TG Therapeutics, Inc.

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02656303     History of Changes
Other Study ID Numbers: UTX-TGR-204
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs