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NCT02793583 Clinical Trial

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

Mantle Cell Lymphoma Clinical Trial

— UNITY-NHL  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02793583
Other study ID # UTX-TGR-205
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date May 25, 2016
Est. completion date July 4, 2022

Study information
Verified date July 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

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).

Recruitment information / eligibility
Status Terminated
Enrollment 710
Est. completion date July 4, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Ublituximab

Drug:
• Umbralisib

Biological:
• Bendamustine

Locations
Country Name City State
Australia TG Therapeutics Investigational Trial Site Adelaide South Australia
Australia TG Therapeutics Investigational Trial Site Benowa Queensland
Australia TG Therapeutics Investigational Trial Site Gosford New South Wales
Australia TG Therapeutics Investigational Trial Site Gosford
Australia TG Therapeutics Investigational Trial Site Heidelberg Victoria
Australia TG Therapeutics Investigational Trial Site Nedlands Western Australia
Australia TG Therapeutics Investigational Trial Site Netherlands Western Australia
Australia TG Therapeutics Investigational Trial Site South Brisbane Queensland
Australia TG Therapeutics Investigational Trial Site Wahroonga New South Wales
Israel TG Therapeutics Investigational Trial Site 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 Tel Aviv
Italy TG Therapeutics Investigational Trial Site Bologna
Italy TG Therapeutics Investigational Trial Site Ferrara
Italy TG Therapeutics Investigational Trial Site Milan
Italy TG Therapeutics Investigational Trial Site Milan
Italy TG Therapeutics Investigational Trial Site Rome
Italy TG Therapeutics Investigational Trial Site Torino
Korea, Republic of TG Therapeutics Investigational Trial Site Busan
Korea, Republic of TG Therapeutics Investigational Trial Site Busan
Korea, Republic of TG Therapeutics Investigational Trial Site Gyeonggi-do
Korea, Republic of TG Therapeutics Investigational Trial Site Incheon
Korea, Republic of TG Therapeutics Investigational Trial Site Seoul
Korea, Republic of TG Therapeutics Investigational Trial Site Seoul
Korea, Republic of TG Therapeutics Investigational Trial Site Seoul
Poland TG Therapeutics Investigational Trial Site Chorzów
Poland TG Therapeutics Investigational Trial Site Gdynia
Poland TG Therapeutics Investigational Trial Site Kraków
Poland TG Therapeutics Investigational Trial Site Lódz
Poland TG Therapeutics Investigational Trial Site Lublin
Poland TG Therapeutics Investigational Trial Site Slupsk
Poland TG Therapeutics Investigational Trial Site Warszawa
Poland TG Therapeutics Investigational Trial Site Warszawa
Poland TG Therapeutics Investigational Trial Site Wroclaw
Slovakia TG Therapeutics Investigational Trial Site Bratislava
Slovakia TG Therapeutics Investigational Trial Site Bratislava
Slovakia TG Therapeutics Investigational Trial Site Košice
Slovakia TG Therapeutics Investigational Trial Site Poprad
Spain TG Therapeutics Investigational Trial Site Barcelona
Spain TG Therapeutics Investigational Trial Site Barcelona
Spain TG Therapeutics Investigational Trial Site Madrid
Spain TG Therapeutics Investigational Trial Site Madrid
Spain TG Therapeutics Investigational Trial Site Salisbury
Spain TG Therapeutics Investigational Trial Site Valencia
United Kingdom TG Therapeutics Investigational Trial Site Cambridge
United Kingdom TG Therapeutics Investigational Trial Site Denmark Hill
United Kingdom TG Therapeutics Investigational Trial Site Leeds
United Kingdom TG Therapeutics Investigational Trial Site Liverpool
United Kingdom TG Therapeutics Investigational Trial Site London
United Kingdom TG Therapeutics Investigational Trial Site London
United Kingdom TG Therapeutics Investigational Trial Site Oxford
United Kingdom TG Therapeutics Investigational Trial Site Plymouth
United States TG Therapeutics Investigational Trial Site Albany Georgia
United States TG Therapeutics Investigational Trial Site Ann Arbor Michigan
United States TG Therapeutics Investigational Trial Site Aurora Colorado
United States TG Therapeutics Investigational Trial Site Austin Texas
United States TG Therapeutics Investigational Trial Site Baltimore Maryland
United States TG Therapeutics Investigational Trial Site Bethesda Maryland
United States TG Therapeutics Investigational Trial Site Billings Montana
United States TG Therapeutics Investigational Trial Site Birmingham Alabama
United States TG Therapeutics Investigational Trial Site Blacksburg Virginia
United States TG Therapeutics Investigational Trial Site Boca Raton Florida
United States TG Therapeutics Investigational Trial Site Brewer Maine
United States TG Therapeutics Investigational Trial Site Bridgeport Connecticut
United States TG Therapeutics Investigational Trial Site Bronx New York
United States TG Therapeutics Investigational Trial Site Buffalo New York
United States TG Therapeutics Investigational Trial Site Camp Hill Pennsylvania
United States TG Therapeutics Investigational Trial Site Canton Ohio
United States TG Therapeutics Investigational Trial Site Chandler Arizona
United States TG Therapeutics Investigational Trial Site Charlotte North Carolina
United States TG Therapeutics Investigational Trial Site Chattanooga Tennessee
United States TG Therapeutics Investigational Trial Site Chicago Illinois
United States TG Therapeutics Investigational Trial Site Chicago Illinois
United States TG Therapeutics Investigational Trial Site Cincinnati Ohio
United States TG Therapeutics Investigational Trial Site Cincinnati Ohio
United States TG Therapeutics Investigational Trial Site Cleveland Ohio
United States TG Therapeutics Investigational Trial Site Columbia Missouri
United States TG Therapeutics Investigational Trial Site Columbia Maryland
United States TG Therapeutics Investigational Trial Site Columbus Ohio
United States TG Therapeutics Investigational Trial Site Covington Louisiana
United States TG Therapeutics Investigational Trial Site Dallas Texas
United States TG Therapeutics Investigational Trial Site Decatur Illinois
United States TG Therapeutics Investigational Trial Site Denver Colorado
United States TG Therapeutics Investigational Trial Site Duluth Minnesota
United States TG Therapeutics Investigational Trial Site Durham North Carolina
United States TG Therapeutics Investigational Trial Site Evanston Illinois
United States TG Therapeutics Investigational Trial Site Farmington New Mexico
United States TG Therapeutics Investigational Trial Site Fort Collins Colorado
United States TG Therapeutics Investigational Trial Site Fort Myers Florida
United States TG Therapeutics Investigational Trial Site Fort Sam Houston Texas
United States TG Therapeutics Investigational Trial Site Fort Wayne Indiana
United States TG Therapeutics Investigational Trial Site Gainesville Florida
United States TG Therapeutics Investigational Trial Site Greenville South Carolina
United States TG Therapeutics Investigational Trial Site Hackensack New Jersey
United States TG Therapeutics Investigational Trial Site Harvey Illinois
United States TG Therapeutics Investigational Trial Site Hickory North Carolina
United States TG Therapeutics Investigational Trial Site Houston Texas
United States TG Therapeutics Investigational Trial Site Huntsville Alabama
United States TG Therapeutics Investigational Trial Site Indianapolis Indiana
United States TG Therapeutics Investigational Trial Site Jacksonville Florida
United States TG Therapeutics Investigational Trial Site Jacksonville Florida
United States TG Therapeutics Investigational Trial Site Jacksonville Florida
United States TG Therapeutics Investigational Trial Site Kansas City Missouri
United States TG Therapeutics Investigational Trial Site Kingsport Tennessee
United States TG Therapeutics Investigational Trial Site Kinston North Carolina
United States TG Therapeutics Investigational Trial Site Knoxville Tennessee
United States TG Therapeutics Investigational Trial Site Lebanon New Hampshire
United States TG Therapeutics Investigational Trial Site Lincoln Nebraska
United States TG Therapeutics Investigational Trial Site Los Angeles California
United States TG Therapeutics Investigational Trial Site Louisville Kentucky
United States TG Therapeutics Investigational Trial Site Macon Georgia
United States TG Therapeutics Investigational Trial Site Madison Wisconsin
United States TG Therapeutics Investigational Trial Site Marietta Georgia
United States TG Therapeutics Investigational Trial Site Maywood Illinois
United States TG Therapeutics Investigational Trial Site Memphis Tennessee
United States TG Therapeutics Investigational Trial Site Miami Florida
United States TG Therapeutics Investigational Trial Site Morristown New Jersey
United States TG Therapeutics Investigational Trial Site Mount Holly New Jersey
United States TG Therapeutics Investigational Trial Site New York New York
United States TG Therapeutics Investigational Trial Site Newark Delaware
United States TG Therapeutics Investigational Trial Site Newport News Virginia
United States TG Therapeutics Investigational Trial Site Niles Illinois
United States TG Therapeutics Investigational Trial Site Ogden Utah
United States TG Therapeutics Investigational Trial Site Olympia Washington
United States TG Therapeutics Investigational Trial Site Omaha Nebraska
United States TG Therapeutics Investigational Trial Site Orange California
United States TG Therapeutics Investigational Trial Site Peoria Illinois
United States TG Therapeutics Investigational Trial Site Philadelphia Pennsylvania
United States TG Therapeutics Investigational Trial Site Portland Oregon
United States TG Therapeutics Investigational Trial Site Portland Oregon
United States TG Therapeutics Investigational Trial Site Providence Rhode Island
United States TG Therapeutics Investigational Trial Site Raleigh North Carolina
United States TG Therapeutics Investigational Trial Site Saint Louis Missouri
United States TG Therapeutics Investigational Trial Site Saint Louis Park Minnesota
United States TG Therapeutics Investigational Trial Site Saint Petersburg Florida
United States TG Therapeutics Investigational Trial Site San Antonio Texas
United States TG Therapeutics Investigational Trial Site San Antonio Texas
United States TG Therapeutics Investigational Trial Site San Antonio Texas
United States TG Therapeutics Investigational Trial Site San Diego California
United States TG Therapeutics Investigational Trial Site San Diego California
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Sioux Falls South Dakota
United States TG Therapeutics Investigational Trial Site Spokane Washington
United States TG Therapeutics Investigational Trial Site Springfield Oregon
United States TG Therapeutics Investigational Trial Site Swansea Illinois
United States TG Therapeutics Investigational Trial Site Syracuse New York
United States TG Therapeutics Investigational Trial Site Tallahassee Florida
United States TG Therapeutics Investigational Trial Site Tampa Florida
United States TG Therapeutics Investigational Trial Site Toledo Ohio
United States TG Therapeutics Investigational Trial Site Towson Maryland
United States TG Therapeutics Investigational Trial Site Tucson Arizona
United States TG Therapeutics Investigational Trial Site Tucson Arizona
United States TG Therapeutics Investigational Trial Site Tyler Texas
United States TG Therapeutics Investigational Trial Site Vancouver Washington
United States TG Therapeutics Investigational Trial Site Washington District of Columbia
United States TG Therapeutics Investigational Trial Site Washington North Carolina
United States TG Therapeutics Investigational Trial Site Watertown South Dakota
United States TG Therapeutics Investigational Trial Site Wauwatosa Wisconsin
United States TG Therapeutics Investigational Trial Site West Palm Beach Florida
United States TG Therapeutics Investigational Trial Site Westwood Kansas
United States TG Therapeutics Investigational Trial Site Whittier California

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Israel,  Italy,  Korea, Republic of,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Response Rate Every 8-12 weeks, up to 2 years
Secondary Progression-Free Survival From date of randomization until the date of first documented progression, assessed up through 2 years
See also
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Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Recruiting NCT05471843 - Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma Phase 1/Phase 2
Recruiting NCT05076097 - A Study of OLR in First-line Treatment of Mantle Cell Lymphoma Phase 2
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT03891355 - Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL Phase 2
Recruiting NCT04883437 - Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas Phase 2
Terminated NCT03585725 - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Early Phase 1
Recruiting NCT02892695 - PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma Phase 1/Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT01665768 - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Phase 2
Completed NCT01437709 - Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant Phase 2
Completed NCT00963534 - Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. Phase 1/Phase 2
Completed NCT00921414 - Mantel Cell Lymphoma Efficacy of Rituximab Maintenance Phase 3
Withdrawn NCT00541424 - Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma N/A
Completed NCT01456351 - Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab Phase 3
Completed NCT01851551 - Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL Phase 1/Phase 2
Completed NCT03295240 - The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma Early Phase 1