Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)

July 19, 2023 updated by: TG Therapeutics, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

603

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • 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
        • TG Therapeutics Investigational Trial Site
  • Italy
      • 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
        • TG Therapeutics Investigational Trial Site
  • Poland
      • 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
        • TG Therapeutics Investigational Trial Site
  • Russian Federation
      • 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
        • TG Therapeutics Investigational Trial Site
  • Spain
      • Barcelona, Spain
        • TG Therapeutics Investigational Trial Site
      • Madrid, Spain
        • TG Therapeutics Investigational Trial Site
      • Valencia, Spain
        • TG Therapeutics Investigational Trial Site
  • United Kingdom
      • 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
        • TG Therapeutics Investigational Trial Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
      • Mobile, Alabama, United States, 36604
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • 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
        • TG Therapeutics Investigational Trial Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • TG Therapeutics Investigational Trial Site
    • California
      • 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
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • TG Therapeutics Investigational Trial Site
      • Denver, Colorado, United States, 80218
        • TG Therapeutics Investigational Trial Site
    • Connecticut
      • 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
        • TG Therapeutics Investigational Trial Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • TG Therapeutics Investigational Trial Site
    • Florida
      • 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
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Albany, Georgia, United States, 31701
        • TG Therapeutics Investigational Trial Site
      • Macon, Georgia, United States, 31201
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • 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
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • TG Therapeutics Investigational Trial Site
      • Indianapolis, Indiana, United States, 46237
        • TG Therapeutics Investigational Trial Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • TG Therapeutics Investigational Trial Site
      • Cedar Rapids, Iowa, United States, 52403
        • TG Therapeutics Investigational Trial Site
    • Kansas
      • Kansas City, Kansas, United States, 64132
        • TG Therapeutics Investigational Trial Site
      • Westwood, Kansas, United States, 66210
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • 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
        • TG Therapeutics Investigational Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TG Therapeutics Investigational Trial Site
      • Worcester, Massachusetts, United States, 01608
        • TG Therapeutics Investigational Trial Site
    • Michigan
      • 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
        • TG Therapeutics Investigational Trial Site
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • TG Therapeutics Investigational Trial Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • TG Therapeutics Investigational Trial Site
      • Kansas City, Missouri, United States
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • TG Therapeutics Investigational Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • TG Therapeutics Investigational Trial Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • TG Therapeutics Investigational Trial Site
      • Somerville, New Jersey, United States, 00876
        • TG Therapeutics Investigational Trial Site
    • New York
      • 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
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • 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
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • 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
        • TG Therapeutics Investigational Trial Site
    • Oregon
      • 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
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • 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
        • TG Therapeutics Investigational Trial Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 00286
        • TG Therapeutics Investigational Trial Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • TG Therapeutics Investigational Trial Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • TG Therapeutics Investigational Trial Site
      • Watertown, South Dakota, United States, 57201
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • TG Therapeutics Investigational Trial Site
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Investigational Trial Site
    • Texas
      • 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, 78229
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, United States, 78217
        • TG Therapeutics Investigational Trial Site
      • Tyler, Texas, United States, 75702
        • TG Therapeutics Investigational Trial Site
    • Utah
      • Ogden, Utah, United States, 84405
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • 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
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Olympia, Washington, United States, 98502
        • TG Therapeutics Investigational Trial Site
      • Seattle, Washington, United States, 98109
        • TG Therapeutics Investigational Trial Site
      • Seattle, Washington, United States, 98104
        • 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
        • TG Therapeutics Investigational Trial Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • TG Therapeutics Investigational Trial Site
      • Wauwatosa, Wisconsin, United States, 53226
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ublituximab + TGR-1202
  • Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
  • TGR-1202: Fixed oral daily dose
Biological: Ublituximab
Ublituximab: IV infusion
Drug: TGR-1202
TGR-1202: Oral daily dose
Active Comparator: Obinutuzumab + Chlorambucil
  • Obinutuzumab: IV infusion dose on Days 1, 8 and 15 in Cycle 1 followed by Day 1 infusion in Cycles 2 - 6
  • Chlorambucil: Oral dose on Days 1 and 15 of Cycles 1 - 6
Biological: Obinutuzumab
Obinutuzumab: IV infusion
Other Names:
  • GAZYVA
Drug: Chlorambucil
Chlorambucil: Oral dose
Other Names:
  • Leukeran
Experimental: Ublituximab
- Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
Biological: Ublituximab
Ublituximab: IV infusion
Experimental: TGR-1202
- TGR-1202: Fixed oral daily dose
Drug: TGR-1202
TGR-1202: Oral daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of first documented progression, assessed up through 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 12 weeks up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2015

Primary Completion (Actual)

February 22, 2023

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTX-TGR-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Ublituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe