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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)

Primary Purpose

Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ublituximab
Umbralisib
Bendamustine
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring DLBCL, FL, MZL, MCL, SLL, Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TG Therapeutics Investigational Trial Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Umbralisib + Ublituximab

Umbralisib

Umbralisib + Ublituximab + Bendamustine

Arm Description

Umbralisib oral daily dose in combination with Ublituximab intravenous administration

Umbralisib oral daily dose

Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Progression-Free Survival

Full Information

First Posted
May 23, 2016
Last Updated
July 20, 2022
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02793583
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business Decision
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
July 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbralisib + Ublituximab
Arm Type
Experimental
Arm Description
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Arm Title
Umbralisib
Arm Type
Experimental
Arm Description
Umbralisib oral daily dose
Arm Title
Umbralisib + Ublituximab + Bendamustine
Arm Type
Experimental
Arm Description
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Intervention Type
Biological
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202
Intervention Type
Biological
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
Every 8-12 weeks, up to 2 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
From date of randomization until the date of first documented progression, assessed up through 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Owen A O'Connor, MD, PhD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Diego
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
97277
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
02250
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
02076
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Benowa
State/Province
Queensland
ZIP/Postal Code
04217
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
04101
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
05000
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
03084
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
06009
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Netherlands
State/Province
Western Australia
ZIP/Postal Code
06009
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Gosford
ZIP/Postal Code
2076
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Haifa
ZIP/Postal Code
91031
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Tel Aviv
ZIP/Postal Code
6971028
Country
Israel
Facility Name
TG Therapeutics Investigational Trial Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Ferrara
ZIP/Postal Code
44020
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
TG Therapeutics Investigational Trial Site
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
TG Therapeutics Investigational Trial Site
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Bratislava
ZIP/Postal Code
81250
Country
Slovakia
Facility Name
TG Therapeutics Investigational Trial Site
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
TG Therapeutics Investigational Trial Site
City
Košice
ZIP/Postal Code
04191
Country
Slovakia
Facility Name
TG Therapeutics Investigational Trial Site
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
TG Therapeutics Investigational Trial Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Salisbury
ZIP/Postal Code
37007
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
TG Therapeutics Investigational Trial Site
City
Cambridge
ZIP/Postal Code
CB2-0QQ
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Denmark Hill
ZIP/Postal Code
SE5-9RS
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Leeds
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Liverpool
ZIP/Postal Code
L7-8XP
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
London
ZIP/Postal Code
EC1A-7BE
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
London
ZIP/Postal Code
SW170QT
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Oxford
ZIP/Postal Code
OX37LE
Country
United Kingdom
Facility Name
TG Therapeutics Investigational Trial Site
City
Plymouth
ZIP/Postal Code
PL68DH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared once the last patient visit has been completed
Citations:
PubMed Identifier
33683917
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.
Results Reference
derived

Learn more about this 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

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