Clinical Trials /

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)

NCT03801525

Description:

ULTRA-V: 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)

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

URL:

https://clinicaltrials.gov/show/NCT03801525

Trial Eligibility

Document

Title

  • 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)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: U2-VEN-207
  • NCT ID: NCT03801525

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
UblituximabTG-1101ublituximab + umbralisib
UmbralisibTGR-1202ublituximab + umbralisib
VenetoclaxVenclextaublituximab + umbralisib + venetoclax

Purpose

ULTRA-V: 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)

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

Trial Arms

NameTypeDescriptionInterventions
ublituximab + umbralisib + venetoclaxExperimental
  • Ublituximab
  • Umbralisib
  • Venetoclax
ublituximab + umbralisibExperimental
  • Ublituximab
  • Umbralisib

Eligibility Criteria

        Inclusion Criteria:

          -  Chronic Lymphocytic Leukemia (CLL) 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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free Survival
Time Frame:60 months
Safety Issue:
Description:Progression-Free Survival in subjects treated with U2+V compared with U2

Secondary Outcome Measures

Measure:Adverse Events That Are Related to Treatment
Time Frame:6 months of therapy
Safety Issue:
Description:Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
Measure:Overall Response Rate
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response in subjects treated with ublituximab + umbralisib + venetoclax

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:TG Therapeutics, Inc.

Trial Keywords

  • CLL

Last Updated

August 23, 2021