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

Status: Active

Description

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

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.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: In review
Name Not Available
San Diego
University of California San Diego
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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 Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
TG Therapeutics Inc

Trial IDs

Primary ID U2-VEN-207
Secondary IDs NCI-2019-01047
Clinicaltrials.gov ID NCT03801525