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Study to Assess the Efficacy and Safety of Ublituximab Plus Umbralisib in Combination With Venetoclax in Subjects With CLL

NCT03801525

Description:

ULTRA-V: Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) in Subjects with Chronic Lymphocytic Leukemia (CLL)

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03801525

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess the Efficacy and Safety of Ublituximab Plus Umbralisib in Combination With Venetoclax in Subjects With CLL
  • Official Title: Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) 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 + venetoclax
UmbralisibTGR-1202ublituximab + umbralisib + venetoclax
VenetoclaxVenclextaublituximab + umbralisib + venetoclax

Purpose

Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with CLL.

Detailed Description

      This is an open-label, multicenter, Phase II study designed to investigate the efficacy and
      safety of ublituximab and umbralisib combined with venetoclax in subjects with Chronic
      Lymphocytic Leukemia.

Trial Arms

NameTypeDescriptionInterventions
ublituximab + umbralisib + venetoclaxExperimentalublituximab: 900 mg; to be administered through cycle 6 only umbralisib: 800 mg; to be administered daily venetoclax: to begin at cycle 4 (dose ramp-up schedule) and continue through cycle 24
  • Ublituximab
  • Umbralisib
  • Venetoclax

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.

          -  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:Overall Response Rate
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response in subjects treated with ublituximab + umbralisib + venetoclax

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

Details

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

Trial Keywords

  • CLL

Last Updated

February 10, 2020