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Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) (ULTRA-V)

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, SLL

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
  • Adequate organ system function as specified in the protocol
  • Ability to follow protocol procedures.

Exclusion Criteria:

  • Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1
  • Prior exposure to any PI3K inhibitor or venetoclax
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded
  • Active Hepatitis B or Hepatitis C.

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 2: Previously Treated CLL (BTK-Not Refractory)

Phase 2: Previously Treated CLL (BTK-Refractory)

Phase 2: Treatment Naïve CLL

Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)

Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)

Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)

Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)

Arm Description

Outcomes

Primary Outcome Measures

Phase 2: Complete Response (CR) Rate
Phase 2: Overall Response Rate
Phase 3: Progression-Free Survival
Progression-Free Survival in subjects treated with U2-V compared with U2

Secondary Outcome Measures

Adverse Events That Are Related to Treatment
Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
Phase 3: Overall Response Rate
Objective response in subjects treated with ublituximab + umbralisib + venetoclax
Rate of Undetectable Minimal Residual Disease (MRD)
Phase 2: Time to Response (TTR)
Phase 2: Duration of Response (DOR)
Phase 3: Complete Response (CR) Rate
Phase 3: Overall Survival (OS)

Full Information

First Posted
January 9, 2019
Last Updated
April 6, 2023
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03801525
Brief Title
Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
Acronym
ULTRA-V
Official Title
Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business decision
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
Detailed Description
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
CLL, SLL

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Phase 2: Previously Treated CLL (BTK-Not Refractory)
Arm Type
Experimental
Arm Title
Phase 2: Previously Treated CLL (BTK-Refractory)
Arm Type
Experimental
Arm Title
Phase 2: Treatment Naïve CLL
Arm Type
Experimental
Arm Title
Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
Arm Type
Experimental
Arm Title
Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
Arm Type
Experimental
Arm Title
Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
Arm Type
Experimental
Arm Title
Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody administered as an intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202, UKONIQ
Intervention Description
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e) Tablet form
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta®
Intervention Description
B-cell lymphoma 2 (BCL-2) inhibitor Tablet form, to be taken orally
Primary Outcome Measure Information:
Title
Phase 2: Complete Response (CR) Rate
Time Frame
Up to 12 months
Title
Phase 2: Overall Response Rate
Time Frame
Up to 12 months
Title
Phase 3: Progression-Free Survival
Description
Progression-Free Survival in subjects treated with U2-V compared with U2
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Adverse Events That Are Related to Treatment
Description
Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
Time Frame
6 months of therapy
Title
Phase 3: Overall Response Rate
Description
Objective response in subjects treated with ublituximab + umbralisib + venetoclax
Time Frame
Up to 12 months
Title
Rate of Undetectable Minimal Residual Disease (MRD)
Time Frame
60 months
Title
Phase 2: Time to Response (TTR)
Time Frame
Up to 12 months
Title
Phase 2: Duration of Response (DOR)
Time Frame
60 months
Title
Phase 3: Complete Response (CR) Rate
Time Frame
Up to 12 months
Title
Phase 3: Overall Survival (OS)
Time Frame
72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment Adequate organ system function as specified in the protocol Ability to follow protocol procedures. Exclusion Criteria: Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1 Prior exposure to any PI3K inhibitor or venetoclax Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded Active Hepatitis B or Hepatitis C.
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
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
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
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
33901
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
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
TG Therapeutics Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
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
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
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 Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
37210
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
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
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
07960
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
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
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29616
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
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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
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
84405
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
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
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data for this study will be shared after the last patient visit has been completed.

Learn more about this trial

Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

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