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
Conditions the study is for: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma
What is being tested?: Ublituximab, Umbralisib and Bendamustine
Type of treatment: Pill or oral medicine, Injection or infusion
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.

Country

City, postcode or hospital

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

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).

Conditions: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma
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 group	Role	What they receive
Umbralisib + Ublituximab	Experimental	Umbralisib oral daily dose in combination with Ublituximab intravenous administration Receives: Biological: Ublituximab; Drug: Umbralisib
Umbralisib	Experimental	Umbralisib oral daily dose Receives: Drug: Umbralisib
Umbralisib + Ublituximab + Bendamustine	Experimental	Umbralisib 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.

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

Secondary outcomes (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.

25 May 20164 Jul 2022

First posted8 Jun 2016 (estimated)
Study start25 May 2016
Primary completion31 May 2022
Study completion4 Jul 2022

Why it stopped: Strategic/Business Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diffuse Large B-Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02793583
Acronym / sponsor ID: UNITY-NHL / UTX-TGR-205
Conditions: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma
Keywords: DLBCL, FL, MZL, MCL, SLL, Non-Hodgkin's Lymphoma
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic/Business Decision
Enrolment: 710 participants (actual)
Lead sponsor: TG Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 25 May 2016 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 4 Jul 2022 (actual)
First posted: 8 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Umbralisib + Ublituximab	Experimental	Biological: Ublituximab, Drug: UmbralisibUmbralisib oral daily dose in combination with Ublituximab intravenous administration
Umbralisib	Experimental	Drug: UmbralisibUmbralisib oral daily dose
Umbralisib + Ublituximab + Bendamustine	Experimental	Biological: Ublituximab, Drug: Umbralisib, Biological: BendamustineUmbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UblituximabAlso: TG-1101	Biological	Umbralisib + Ublituximab, Umbralisib + Ublituximab + Bendamustine
UmbralisibAlso: TGR-1202	Drug	Umbralisib, Umbralisib + Ublituximab, Umbralisib + Ublituximab + Bendamustine
BendamustineAlso: Treanda	Biological	Umbralisib + Ublituximab + Bendamustine

Primary outcome

Overall Response Rate
Time frame: Every 8-12 weeks, up to 2 years

1 secondary outcome

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

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
Derived from this study: PubMed 33683917Fowler 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.
Individual participant dataSharing planned: Yes. Data will be shared once the last patient visit has been completed

Related trials for Diffuse Large B-Cell Lymphoma

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Study of Oral MRT-2359 in Selected Cancer Patients
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Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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Not yet recruitingPhase 2
The CARDIOPROTECT Trial
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QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
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Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Owen A O'Connor, MD, PhD study chair

Columbia University

168 sites in 9 countries: see every site and its status.

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.