Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma (UNITY-NHL)

July 20, 2022 updated by: TG Therapeutics, Inc.

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

Study Type

Interventional

Enrollment (Actual)

710

Phase

  • Phase 2
  • 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

  • Australia
      • Gosford, Australia, 2076
        • TG Therapeutics Investigational Trial Site
    • New South Wales
      • Gosford, New South Wales, Australia, 02250
        • TG Therapeutics Investigational Trial Site
      • Wahroonga, New South Wales, Australia, 02076
        • TG Therapeutics Investigational Trial Site
    • Queensland
      • Benowa, Queensland, Australia, 04217
        • TG Therapeutics Investigational Trial Site
      • South Brisbane, Queensland, Australia, 04101
        • TG Therapeutics Investigational Trial Site
    • South Australia
      • Adelaide, South Australia, Australia, 05000
        • TG Therapeutics Investigational Trial Site
    • Victoria
      • Heidelberg, Victoria, Australia, 03084
        • TG Therapeutics Investigational Trial Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 06009
        • TG Therapeutics Investigational Trial Site
      • Netherlands, Western Australia, Australia, 06009
        • TG Therapeutics Investigational Trial Site
  • Israel
      • Ashkelon, Israel, 7830604
        • TG Therapeutics Investigational Trial Site
      • Be'er Sheva, Israel, 8410101
        • TG Therapeutics Investigational Trial Site
      • Haifa, Israel, 91031
        • TG Therapeutics Investigational Trial Site
      • Jerusalem, Israel, 9112001
        • TG Therapeutics Investigational Trial Site
      • Nahariya, Israel, 2210001
        • TG Therapeutics Investigational Trial Site
      • Petah Tikva, Israel, 49100
        • TG Therapeutics Investigational Trial Site
      • Tel Aviv, Israel, 64239
        • TG Therapeutics Investigational Trial Site
      • Tel Aviv, Israel, 6971028
        • TG Therapeutics Investigational Trial Site
  • Italy
      • Bologna, Italy, 40138
        • TG Therapeutics Investigational Trial Site
      • Ferrara, Italy, 44020
        • TG Therapeutics Investigational Trial Site
      • Milan, Italy, 20132
        • TG Therapeutics Investigational Trial Site
      • Milan, Italy, 20141
        • TG Therapeutics Investigational Trial Site
      • Rome, Italy, 00161
        • TG Therapeutics Investigational Trial Site
      • Torino, Italy, 10126
        • TG Therapeutics Investigational Trial Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • TG Therapeutics Investigational Trial Site
      • Busan, Korea, Republic of, 49241
        • TG Therapeutics Investigational Trial Site
      • Gyeonggi-do, Korea, Republic of, 13620
        • TG Therapeutics Investigational Trial Site
      • Incheon, Korea, Republic of, 21565
        • TG Therapeutics Investigational Trial Site
      • Seoul, Korea, Republic of, 03080
        • TG Therapeutics Investigational Trial Site
      • Seoul, Korea, Republic of, 06351
        • TG Therapeutics Investigational Trial Site
      • Seoul, Korea, Republic of, 06591
        • TG Therapeutics Investigational Trial Site
  • Poland
      • Chorzów, Poland, 41-500
        • TG Therapeutics Investigational Trial Site
      • Gdynia, Poland, 81-519
        • TG Therapeutics Investigational Trial Site
      • Kraków, Poland, 30-510
        • TG Therapeutics Investigational Trial Site
      • Lublin, Poland, 20-090
        • TG Therapeutics Investigational Trial Site
      • Słupsk, Poland, 76-200
        • TG Therapeutics Investigational Trial Site
      • Warszawa, Poland, 02-781
        • TG Therapeutics Investigational Trial Site
      • Warszawa, Poland, 02-106
        • TG Therapeutics Investigational Trial Site
      • Wrocław, Poland, 50-367
        • TG Therapeutics Investigational Trial Site
      • Łódź, Poland, 93-513
        • TG Therapeutics Investigational Trial Site
  • Slovakia
      • Bratislava, Slovakia, 81250
        • TG Therapeutics Investigational Trial Site
      • Bratislava, Slovakia, 83310
        • TG Therapeutics Investigational Trial Site
      • Košice, Slovakia, 04191
        • TG Therapeutics Investigational Trial Site
      • Poprad, Slovakia, 05801
        • TG Therapeutics Investigational Trial Site
  • Spain
      • Barcelona, Spain, 08035
        • TG Therapeutics Investigational Trial Site
      • Barcelona, Spain, 08041
        • TG Therapeutics Investigational Trial Site
      • Madrid, Spain, 28041
        • TG Therapeutics Investigational Trial Site
      • Madrid, Spain, 28222
        • TG Therapeutics Investigational Trial Site
      • Salisbury, Spain, 37007
        • TG Therapeutics Investigational Trial Site
      • Valencia, Spain, 46010
        • TG Therapeutics Investigational Trial Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2-0QQ
        • TG Therapeutics Investigational Trial Site
      • Denmark Hill, United Kingdom, SE5-9RS
        • TG Therapeutics Investigational Trial Site
      • Leeds, United Kingdom, LS97TF
        • TG Therapeutics Investigational Trial Site
      • Liverpool, United Kingdom, L7-8XP
        • TG Therapeutics Investigational Trial Site
      • London, United Kingdom, SW170QT
        • TG Therapeutics Investigational Trial Site
      • London, United Kingdom, EC1A-7BE
        • TG Therapeutics Investigational Trial Site
      • Oxford, United Kingdom, OX37LE
        • TG Therapeutics Investigational Trial Site
      • Plymouth, United Kingdom, PL68DH
        • TG Therapeutics Investigational Trial Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • TG Therapeutics Investigational Trial Site
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • TG Therapeutics Investigational Trial Site
      • Tucson, Arizona, United States, 85711
        • TG Therapeutics Investigational Trial Site
      • Tucson, Arizona, United States, 85724
        • TG Therapeutics Investigational Trial Site
    • California
      • Los Angeles, California, United States, 90095
        • TG Therapeutics Investigational Trial Site
      • Orange, California, United States, 92868
        • TG Therapeutics Investigational Trial Site
      • San Diego, California, United States, 92108
        • TG Therapeutics Investigational Trial Site
      • San Diego, California, United States, 90710
        • 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
      • Fort Collins, Colorado, United States, 80528
        • TG Therapeutics Investigational Trial Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • TG Therapeutics Investigational Trial Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • TG Therapeutics Investigational Trial Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • 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
      • Gainesville, Florida, United States, 32608
        • TG Therapeutics Investigational Trial Site
      • Jacksonville, Florida, United States, 32224
        • 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
      • Miami, Florida, United States, 33176
        • 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
      • Marietta, Georgia, United States, 30060
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • TG Therapeutics Investigational Trial Site
      • Chicago, Illinois, United States, 60637
        • TG Therapeutics Investigational Trial Site
      • Decatur, Illinois, United States, 62526
        • TG Therapeutics Investigational Trial Site
      • Evanston, Illinois, United States, 60201
        • TG Therapeutics Investigational Trial Site
      • Harvey, Illinois, United States, 60426
        • 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, 62226
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • TG Therapeutics Investigational Trial Site
      • Indianapolis, Indiana, United States, 46237
        • TG Therapeutics Investigational Trial Site
    • Kansas
      • Westwood, Kansas, United States, 66210
        • TG Therapeutics Investigational Trial Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • TG Therapeutics Investigational Trial Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • TG Therapeutics Investigational Trial Site
    • Maine
      • Brewer, Maine, United States, 04412
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • 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
      • Towson, Maryland, United States, 21204
        • TG Therapeutics Investigational Trial Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • TG Therapeutics Investigational Trial Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • TG Therapeutics Investigational Trial Site
      • 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, 64132
        • TG Therapeutics Investigational Trial Site
      • Saint Louis, Missouri, United States, 63110
        • TG Therapeutics Investigational Trial Site
    • Montana
      • Billings, Montana, United States, 59102
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • TG Therapeutics Investigational Trial Site
      • Omaha, Nebraska, United States, 68130
        • TG Therapeutics Investigational Trial Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • TG Therapeutics Investigational Trial Site
      • Morristown, New Jersey, United States, 07962
        • TG Therapeutics Investigational Trial Site
      • Mount Holly, New Jersey, United States, 08060
        • TG Therapeutics Investigational Trial Site
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • TG Therapeutics Investigational Trial Site
    • New York
      • Bronx, New York, United States, 10467
        • TG Therapeutics Investigational Trial Site
      • Buffalo, New York, United States, 14263
        • TG Therapeutics Investigational Trial Site
      • New York, New York, United States, 10019
        • TG Therapeutics Investigational Trial Site
      • Syracuse, New York, United States, 13210
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28201
        • TG Therapeutics Investigational Trial Site
      • Durham, North Carolina, United States, 27705
        • 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, 45220
        • TG Therapeutics Investigational Trial Site
      • Cincinnati, Ohio, United States, 45242
        • TG Therapeutics Investigational Trial Site
      • Cleveland, Ohio, United States, 44106
        • TG Therapeutics Investigational Trial Site
      • Columbus, Ohio, United States, 43219
        • 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, 97213
        • 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
      • Philadelphia, Pennsylvania, United States, 19106
        • TG Therapeutics Investigational Trial Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • 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
      • Kingsport, Tennessee, United States, 37660
        • TG Therapeutics Investigational Trial Site
      • Knoxville, Tennessee, United States, 37916
        • TG Therapeutics Investigational Trial Site
      • Memphis, Tennessee, United States, 38120
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Austin, Texas, United States, 78705
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, United States, 75390
        • TG Therapeutics Investigational Trial Site
      • Fort Sam Houston, Texas, United States, 78234
        • 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
      • San Antonio, Texas, United States, 78130
        • TG Therapeutics Investigational Trial Site
      • Tyler, Texas, United States, 75702
        • TG Therapeutics Investigational Trial Site
    • Utah
      • Ogden, Utah, United States, 84403
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • TG Therapeutics Investigational Trial Site
      • Newport News, Virginia, United States, 23601
        • 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
      • Seattle, Washington, United States, 98108
        • TG Therapeutics Investigational Trial Site
      • Spokane, Washington, United States, 99216
        • TG Therapeutics Investigational Trial Site
      • Vancouver, Washington, United States, 97277
        • TG Therapeutics Investigational Trial Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Non-Hodgkin's Lymphoma including 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
  • MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Umbralisib + Ublituximab
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Biological: Ublituximab
Other Names:
  • TG-1101
Drug: Umbralisib
Other Names:
  • TGR-1202
EXPERIMENTAL: Umbralisib
Umbralisib oral daily dose
Drug: Umbralisib
Other Names:
  • TGR-1202
EXPERIMENTAL: Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Biological: Ublituximab
Other Names:
  • TG-1101
Drug: Umbralisib
Other Names:
  • TGR-1202
Biological: Bendamustine
Other Names:
  • Treanda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: Every 8-12 weeks, up to 2 years
Every 8-12 weeks, up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years
From date of randomization until the date of first documented progression, assessed up through 2 years

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

Investigators

  • Study Chair: Owen A O'Connor, MD, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 25, 2016

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

July 4, 2022

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (ESTIMATE)

June 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTX-TGR-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared once the last patient visit has been completed

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.

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