Clinical trial NCT03801525: 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)
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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: CLL
SLL
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-11
Enrollment: 277
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: 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 participants with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL).

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.

Primary outcomes:
measure: Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
Secondary outcomes:
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to 43.2 months
measure: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 43.2 months
measure: Phase 2: Time to Response (TTR) Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 2: Duration of Response (DOR) Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 3: CR Rate as Assessed by an Independent Review Committee (IRC) Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 3: ORR as Assessed by IRC Per iwCLL 2018 Criteria
timeFrame: Up to 43.2 months
measure: Phase 3: Overall Survival (OS)
timeFrame: Up to 43.2 months
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: Tucson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Duarte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: La Jolla
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: Stamford
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
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: Jacksonville
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: Tampa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Atlanta
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Decatur
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 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: Des Moines
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Iowa
city: Westwood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Louisville
country: United States
facility: TG Therapeutics Investigational Site
state: Kentucky
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: Ann Arbor
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Rochester
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
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: New York
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: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Eugene
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Philadelphia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Charleston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Carolina
city: Greenville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Carolina
city: Chattanooga
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: Nashville
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: 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: Salt Lake City
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: Gainesville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
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
Study officials:
References: