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Diffuse Large B-Cell LymphomaPhase 2/3UNITY-NHLNCT02793583

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

A Phase 2/3 study testing Ublituximab, Umbralisib and Bendamustine in people with Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, run by TG Therapeutics, Inc. at 168 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ublituximab, Umbralisib and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
168 sitesin 9 countries
Study dates
25 May 2016to 4 Jul 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

168 sites in 9 countries.

168 sites in 9 countries

United States111 sites

  • TG Therapeutics Investigational Trial Site

    Albany, Georgia, 31701

  • TG Therapeutics Investigational Trial Site

    Ann Arbor, Michigan, 48109

  • TG Therapeutics Investigational Trial Site

    Aurora, Colorado, 80012

  • TG Therapeutics Investigational Trial Site

    Austin, Texas, 78705

  • TG Therapeutics Investigational Trial Site

    Baltimore, Maryland, 21201

  • TG Therapeutics Investigational Trial Site

    Bethesda, Maryland, 20817

  • TG Therapeutics Investigational Trial Site

    Billings, Montana, 59102

  • TG Therapeutics Investigational Trial Site

    Birmingham, Alabama, 35243

  • TG Therapeutics Investigational Trial Site

    Blacksburg, Virginia, 24060

  • TG Therapeutics Investigational Trial Site

    Boca Raton, Florida, 33486

  • TG Therapeutics Investigational Trial Site

    Brewer, Maine, 04412

  • TG Therapeutics Investigational Trial Site

    Bridgeport, Connecticut, 06606

  • TG Therapeutics Investigational Trial Site

    Buffalo, New York, 14263

  • TG Therapeutics Investigational Trial Site

    Camp Hill, Pennsylvania, 17011

  • TG Therapeutics Investigational Trial Site

    Canton, Ohio, 44718

  • TG Therapeutics Investigational Trial Site

    Chandler, Arizona, 85224

  • TG Therapeutics Investigational Trial Site

    Charlotte, North Carolina, 28201

  • TG Therapeutics Investigational Trial Site

    Chattanooga, Tennessee, 37404

  • TG Therapeutics Investigational Trial Site

    Chicago, Illinois, 60612

  • TG Therapeutics Investigational Trial Site

    Chicago, Illinois, 60637

  • TG Therapeutics Investigational Trial Site

    Cincinnati, Ohio, 45220

  • TG Therapeutics Investigational Trial Site

    Cincinnati, Ohio, 45242

  • TG Therapeutics Investigational Trial Site

    Cleveland, Ohio, 44106

  • TG Therapeutics Investigational Trial Site

    Columbia, Maryland, 21044

  • TG Therapeutics Investigational Trial Site

    Columbia, Missouri, 65212

  • TG Therapeutics Investigational Trial Site

    Columbus, Ohio, 43219

  • TG Therapeutics Investigational Trial Site

    Covington, Louisiana, 70433

  • TG Therapeutics Investigational Trial Site

    Dallas, Texas, 75390

  • TG Therapeutics Investigational Trial Site

    Decatur, Illinois, 62526

  • TG Therapeutics Investigational Trial Site

    Denver, Colorado, 80218

  • TG Therapeutics Investigational Trial Site

    Duluth, Minnesota, 55805

  • TG Therapeutics Investigational Trial Site

    Durham, North Carolina, 27705

  • TG Therapeutics Investigational Trial Site

    Evanston, Illinois, 60201

  • TG Therapeutics Investigational Trial Site

    Farmington, New Mexico, 87401

  • TG Therapeutics Investigational Trial Site

    Fort Collins, Colorado, 80528

  • TG Therapeutics Investigational Trial Site

    Fort Myers, Florida, 33916

  • TG Therapeutics Investigational Trial Site

    Fort Sam Houston, Texas, 78234

  • TG Therapeutics Investigational Trial Site

    Fort Wayne, Indiana, 46845

  • TG Therapeutics Investigational Trial Site

    Gainesville, Florida, 32608

  • TG Therapeutics Investigational Trial Site

    Greenville, South Carolina, 29615

  • TG Therapeutics Investigational Trial Site

    Hackensack, New Jersey, 07601

  • TG Therapeutics Investigational Trial Site

    Harvey, Illinois, 60426

  • TG Therapeutics Investigational Trial Site

    Hickory, North Carolina, 28602

  • TG Therapeutics Investigational Trial Site

    Houston, Texas, 77030

  • TG Therapeutics Investigational Trial Site

    Huntsville, Alabama, 35805

  • TG Therapeutics Investigational Trial Site

    Indianapolis, Indiana, 46237

  • TG Therapeutics Investigational Trial Site

    Jacksonville, Florida, 32204

  • TG Therapeutics Investigational Trial Site

    Jacksonville, Florida, 32224

  • TG Therapeutics Investigational Trial Site

    Jacksonville, Florida, 32256

  • TG Therapeutics Investigational Trial Site

    Kansas City, Missouri, 64132

  • TG Therapeutics Investigational Trial Site

    Kingsport, Tennessee, 37660

  • TG Therapeutics Investigational Trial Site

    Kinston, North Carolina, 28501

  • TG Therapeutics Investigational Trial Site

    Knoxville, Tennessee, 37916

  • TG Therapeutics Investigational Trial Site

    Lebanon, New Hampshire, 03756

  • TG Therapeutics Investigational Trial Site

    Lincoln, Nebraska, 68510

  • TG Therapeutics Investigational Trial Site

    Los Angeles, California, 90095

  • TG Therapeutics Investigational Trial Site

    Louisville, Kentucky, 40207

  • TG Therapeutics Investigational Trial Site

    Macon, Georgia, 31201

  • TG Therapeutics Investigational Trial Site

    Madison, Wisconsin, 53792

  • TG Therapeutics Investigational Trial Site

    Marietta, Georgia, 30060

  • TG Therapeutics Investigational Trial Site

    Maywood, Illinois, 60153

  • TG Therapeutics Investigational Trial Site

    Memphis, Tennessee, 38120

  • TG Therapeutics Investigational Trial Site

    Miami, Florida, 33176

  • TG Therapeutics Investigational Trial Site

    Morristown, New Jersey, 07962

  • TG Therapeutics Investigational Trial Site

    Mount Holly, New Jersey, 08060

  • TG Therapeutics Investigational Trial Site

    New York, New York, 10019

  • TG Therapeutics Investigational Trial Site

    Newark, Delaware, 19713

  • TG Therapeutics Investigational Trial Site

    Newport News, Virginia, 23601

  • TG Therapeutics Investigational Trial Site

    Niles, Illinois, 60714

  • TG Therapeutics Investigational Trial Site

    Ogden, Utah, 84403

  • TG Therapeutics Investigational Trial Site

    Olympia, Washington, 98502

  • TG Therapeutics Investigational Trial Site

    Omaha, Nebraska, 68130

  • TG Therapeutics Investigational Trial Site

    Orange, California, 92868

  • TG Therapeutics Investigational Trial Site

    Peoria, Illinois, 61615

  • TG Therapeutics Investigational Trial Site

    Philadelphia, Pennsylvania, 19106

  • TG Therapeutics Investigational Trial Site

    Portland, Oregon, 97213

  • TG Therapeutics Investigational Trial Site

    Portland, Oregon, 97227

  • TG Therapeutics Investigational Trial Site

    Providence, Rhode Island, 02906

  • TG Therapeutics Investigational Trial Site

    Raleigh, North Carolina, 27607

  • TG Therapeutics Investigational Trial Site

    Saint Louis Park, Minnesota, 55416

  • TG Therapeutics Investigational Trial Site

    San Antonio, Texas, 78130

  • TG Therapeutics Investigational Trial Site

    San Antonio, Texas, 78217

  • TG Therapeutics Investigational Trial Site

    San Antonio, Texas, 78229

  • TG Therapeutics Investigational Trial Site

    San Diego, California, 90710

  • TG Therapeutics Investigational Trial Site

    San Diego, California, 92108

  • TG Therapeutics Investigational Trial Site

    Seattle, Washington, 98104

  • TG Therapeutics Investigational Trial Site

    Seattle, Washington, 98108

  • TG Therapeutics Investigational Trial Site

    Seattle, Washington, 98109

  • TG Therapeutics Investigational Trial Site

    Sioux Falls, South Dakota, 57105

  • TG Therapeutics Investigational Trial Site

    Spokane, Washington, 99216

  • TG Therapeutics Investigational Trial Site

    Springfield, Oregon, 97477

  • TG Therapeutics Investigational Trial Site

    St Louis, Missouri, 63110

  • TG Therapeutics Investigational Trial Site

    St. Petersburg, Florida, 33705

  • TG Therapeutics Investigational Trial Site

    Swansea, Illinois, 62226

  • TG Therapeutics Investigational Trial Site

    Syracuse, New York, 13210

  • TG Therapeutics Investigational Trial Site

    Tallahassee, Florida, 32308

  • TG Therapeutics Investigational Trial Site

    Tampa, Florida, 33612

  • TG Therapeutics Investigational Trial Site

    The Bronx, New York, 10467

  • TG Therapeutics Investigational Trial Site

    Toledo, Ohio, 43623

  • TG Therapeutics Investigational Trial Site

    Towson, Maryland, 21204

  • TG Therapeutics Investigational Trial Site

    Tucson, Arizona, 85711

  • TG Therapeutics Investigational Trial Site

    Tucson, Arizona, 85724

  • TG Therapeutics Investigational Trial Site

    Tyler, Texas, 75702

  • TG Therapeutics Investigational Trial Site

    Vancouver, Washington, 97277

  • TG Therapeutics Investigational Trial Site

    Washington, North Carolina, 27889

  • TG Therapeutics Investigational Trial Site

    Washington D.C., District of Columbia, 20007

  • TG Therapeutics Investigational Trial Site

    Watertown, South Dakota, 57201

  • TG Therapeutics Investigational Trial Site

    Wauwatosa, Wisconsin, 53226

  • TG Therapeutics Investigational Trial Site

    West Palm Beach, Florida, 33407

  • TG Therapeutics Investigational Trial Site

    Westwood, Kansas, 66210

  • TG Therapeutics Investigational Trial Site

    Whittier, California, 90603

Other trials in United States

Australia9 sites

  • TG Therapeutics Investigational Trial Site

    Adelaide, South Australia, 05000

  • TG Therapeutics Investigational Trial Site

    Benowa, Queensland, 04217

  • TG Therapeutics Investigational Trial Site

    Gosford, New South Wales, 02250

  • TG Therapeutics Investigational Trial Site

    Gosford, 2076

  • TG Therapeutics Investigational Trial Site

    Heidelberg, Victoria, 03084

  • TG Therapeutics Investigational Trial Site

    Nedlands, Western Australia, 06009

  • TG Therapeutics Investigational Trial Site

    Netherlands, Western Australia, 06009

  • TG Therapeutics Investigational Trial Site

    South Brisbane, Queensland, 04101

  • TG Therapeutics Investigational Trial Site

    Wahroonga, New South Wales, 02076

Other trials in Australia

Poland9 sites

  • TG Therapeutics Investigational Trial Site

    Chorzów, 41-500

  • TG Therapeutics Investigational Trial Site

    Gdynia, 81-519

  • TG Therapeutics Investigational Trial Site

    Krakow, 30-510

  • TG Therapeutics Investigational Trial Site

    Lodz, 93-513

  • TG Therapeutics Investigational Trial Site

    Lublin, 20-090

  • TG Therapeutics Investigational Trial Site

    Słupsk, 76-200

  • TG Therapeutics Investigational Trial Site

    Warsaw, 02-106

  • TG Therapeutics Investigational Trial Site

    Warsaw, 02-781

  • TG Therapeutics Investigational Trial Site

    Wroclaw, 50-367

Other trials in Poland

Israel8 sites

  • TG Therapeutics Investigational Trial Site

    Ashkelon, 7830604

  • TG Therapeutics Investigational Trial Site

    Beersheba, 8410101

  • TG Therapeutics Investigational Trial Site

    Haifa, 91031

  • TG Therapeutics Investigational Trial Site

    Jerusalem, 9112001

  • TG Therapeutics Investigational Trial Site

    Nahariya, 2210001

  • TG Therapeutics Investigational Trial Site

    Petah Tikva, 49100

  • TG Therapeutics Investigational Trial Site

    Tel Aviv, 64239

  • TG Therapeutics Investigational Trial Site

    Tel Aviv, 6971028

Other trials in Israel

United Kingdom8 sites

  • TG Therapeutics Investigational Trial Site

    Cambridge, CB2-0QQ

  • TG Therapeutics Investigational Trial Site

    Denmark Hill, SE5-9RS

  • TG Therapeutics Investigational Trial Site

    Leeds, LS97TF

  • TG Therapeutics Investigational Trial Site

    Liverpool, L7-8XP

  • TG Therapeutics Investigational Trial Site

    London, EC1A-7BE

  • TG Therapeutics Investigational Trial Site

    London, SW170QT

  • TG Therapeutics Investigational Trial Site

    Oxford, OX37LE

  • TG Therapeutics Investigational Trial Site

    Plymouth, PL68DH

Other trials in United Kingdom

South Korea7 sites

  • TG Therapeutics Investigational Trial Site

    Busan, 47392

  • TG Therapeutics Investigational Trial Site

    Busan, 49241

  • TG Therapeutics Investigational Trial Site

    Gyeonggi-do, 13620

  • TG Therapeutics Investigational Trial Site

    Incheon, 21565

  • TG Therapeutics Investigational Trial Site

    Seoul, 03080

  • TG Therapeutics Investigational Trial Site

    Seoul, 06351

  • TG Therapeutics Investigational Trial Site

    Seoul, 06591

Other trials in South Korea

Italy6 sites

  • TG Therapeutics Investigational Trial Site

    Bologna, 40138

  • TG Therapeutics Investigational Trial Site

    Ferrara, 44020

  • TG Therapeutics Investigational Trial Site

    Milan, 20132

  • TG Therapeutics Investigational Trial Site

    Milan, 20141

  • TG Therapeutics Investigational Trial Site

    Rome, 00161

  • TG Therapeutics Investigational Trial Site

    Torino, 10126

Other trials in Italy

Spain6 sites

  • TG Therapeutics Investigational Trial Site

    Barcelona, 08035

  • TG Therapeutics Investigational Trial Site

    Barcelona, 08041

  • TG Therapeutics Investigational Trial Site

    Madrid, 28041

  • TG Therapeutics Investigational Trial Site

    Madrid, 28222

  • TG Therapeutics Investigational Trial Site

    Salisbury, 37007

  • TG Therapeutics Investigational Trial Site

    Valencia, 46010

Other trials in Spain

Slovakia4 sites

  • TG Therapeutics Investigational Trial Site

    Bratislava, 81250

  • TG Therapeutics Investigational Trial Site

    Bratislava, 83310

  • TG Therapeutics Investigational Trial Site

    Košice, 04191

  • TG Therapeutics Investigational Trial Site

    Poprad, 05801

Other trials in Slovakia

About this study

Official title: 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

Read the 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).

Being tested
Ublituximab, Umbralisib, Bendamustine
Keywords
DLBCL, FL, MZL, MCL, SLL, Non-Hodgkin's Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UblituximabBiological

    Also called TG-1101

  • UmbralisibDrug

    Also called TGR-1202

  • BendamustineBiological

    Also called Treanda

Study groups in NCT02793583
Study groupRoleWhat they receive
Umbralisib + UblituximabExperimentalUmbralisib oral daily dose in combination with Ublituximab intravenous administration
Receives: Biological: Ublituximab; Drug: Umbralisib
UmbralisibExperimentalUmbralisib oral daily dose
Receives: Drug: Umbralisib
Umbralisib + Ublituximab + BendamustineExperimentalUmbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Receives: Biological: Ublituximab; Drug: Umbralisib; Biological: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Measured: Every 8-12 weeks, up to 2 years

Secondary outcomes (1)

  1. Progression-Free Survival

    Measured: From date of randomization until the date of first documented progression, assessed up through 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study start25 May 2016
  3. Primary completion31 May 2022
  4. Study completion4 Jul 2022

Why it stopped: Strategic/Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793583
Sponsor's protocol ID
UTX-TGR-205
Acronym
UNITY-NHL
Status last verified
Jul 2022
First submitted
23 May 2016
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data will be shared once the last patient visit has been completed

Publications

  • Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, Knopinska-Posluszny W, Cheah CY, Phillips T, Lech-Maranda E, Cheson BD, Caimi PF, Grosicki S, Leslie LA, Chavez JC, Fonseca G, Babu S, Hodson DJ, Shao SH, Burke JM, Sharman JP, Law JY, Pagel JM, Miskin HP, Sportelli P, O'Connor OA, Weiss MS, Zinzani PL. Umbralisib, a Dual PI3Kdelta/CK1epsilon Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021 May 20;39(15):1609-1618. doi: 10.1200/JCO.20.03433. Epub 2021 Mar 8.

    PubMed 33683917

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ublituximab, Umbralisib and Bendamustine in people with Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, run by TG Therapeutics, Inc. at 168 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, Australia, Poland, Israel, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic/Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Every 8-12 weeks, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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