Clinical trial NCT02793583: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
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
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Every 8-12 weeks, up to 2 years
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: From date of randomization until the date of first documented progression, assessed up through 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Chandler
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Tucson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Tucson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Los Angeles
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Orange
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: San Diego
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: San Diego
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Whittier
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Aurora
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Denver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Fort Collins
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Bridgeport
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: Newark
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Delaware
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: District of Columbia
city: Boca Raton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Fort Myers
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Gainesville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Jacksonville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Jacksonville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Jacksonville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Miami
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Saint Petersburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Tallahassee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Tampa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: West Palm Beach
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Albany
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Macon
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Marietta
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Chicago
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Chicago
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Decatur
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Evanston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Harvey
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Maywood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Niles
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Peoria
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Swansea
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Fort Wayne
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Indianapolis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Westwood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Louisville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Covington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Louisiana
city: Brewer
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maine
city: Baltimore
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Bethesda
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Columbia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Towson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Ann Arbor
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Duluth
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Columbia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
city: Kansas City
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
city: Saint Louis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
city: Billings
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Montana
city: Lincoln
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Omaha
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Lebanon
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Hampshire
city: Hackensack
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Morristown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Mount Holly
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Farmington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Mexico
city: Bronx
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Buffalo
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Syracuse
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Charlotte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Hickory
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Kinston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Raleigh
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Canton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Cincinnati
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Cincinnati
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Cleveland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Toledo
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Springfield
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Camp Hill
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Providence
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Rhode Island
city: Greenville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Carolina
city: Sioux Falls
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Dakota
city: Watertown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Dakota
city: Chattanooga
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Kingsport
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Knoxville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Memphis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Dallas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Fort Sam Houston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Houston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Tyler
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Ogden
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Utah
city: Blacksburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Newport News
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Olympia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Spokane
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Vancouver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Madison
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Wauwatosa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Gosford
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: New South Wales
city: Wahroonga
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: New South Wales
city: Benowa
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Queensland
city: South Brisbane
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Queensland
city: Adelaide
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: South Australia
city: Heidelberg
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Victoria
city: Nedlands
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Western Australia
city: Netherlands
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Western Australia
city: Gosford
country: Australia
facility: TG Therapeutics Investigational Trial Site
city: Ashkelon
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Be'er Sheva
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Haifa
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Jerusalem
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Nahariya
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Petah Tikva
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Tel Aviv
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Tel Aviv
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Bologna
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Ferrara
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Milan
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Milan
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Rome
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Torino
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Busan
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Busan
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Gyeonggi-do
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Incheon
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Seoul
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Seoul
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Seoul
country: Korea, Republic of
facility: TG Therapeutics Investigational Trial Site
city: Chorzów
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Gdynia
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Kraków
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Lublin
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Słupsk
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Wrocław
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Łódź
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Bratislava
country: Slovakia
facility: TG Therapeutics Investigational Trial Site
city: Bratislava
country: Slovakia
facility: TG Therapeutics Investigational Trial Site
city: Košice
country: Slovakia
facility: TG Therapeutics Investigational Trial Site
city: Poprad
country: Slovakia
facility: TG Therapeutics Investigational Trial Site
city: Barcelona
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Barcelona
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Madrid
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Madrid
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Salisbury
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Valencia
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Cambridge
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Denmark Hill
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Leeds
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Liverpool
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: London
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: London
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Oxford
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Plymouth
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
Study officials:
affiliation: Columbia University
name: Owen A O'Connor, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.