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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)

Clinical Trial Details

TG Therapeutics, Inc is doing this research study to determine the safety and effectiveness of the combination of the study drug(s) ublituximab (also called TG-1101), umbralisib (also called TGR-1202), and the FDA approved drug, venetoclax. This study is also designed to learn if this combination will cause your disease to be undetectable in your blood and/or bone marrow. The study doctors will also be looking at how the study drug umbralisib and the FDA approved drug venetoclax will impact each other regarding the levels of either study drug in your blood. 

Ublituximab is a monoclonal antibody that targets CD20. Antibody therapy targets and attaches to the CD20 protein found on the surface of both CLL cells and some healthy blood cells. Once attached to the CD20 protein, ublituximab is thought to work in two different ways: 

  • By helping your own immune system destroy the cancer cells 
  • By destroying the cancer cells directly 

Umbralisib is a PI3K (Phosphatidylinositol 3-kinase delta) inhibitor. It works by blocks PI3K,which is protein that helps cells grow. In your type of cancer extra PI3K is made and it is more active than usual. By blocking PI3K it may slow the growth of CLL cells. 

"Investigational" means the study drugs being tested (ublituximab and umbralisib) have not been approved by the United States Food and Drug Administration (FDA), and are for use only in a research study for people with your type of cancer. Venetoclax is approved by the FDA for subjects with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, which is a cytogenetic abnormality, who have received at least one prior treatment. 

If you qualify for the study, you will: 

  • Visit the study doctor on schedule. 
  • Tell the study doctor about any changes in how you are feeling or about any problems you have during the study 
  • Talk with the study doctor before starting any new medications during the study 
  • Have tests and procedures, as described in the following section 
  • Never share any of the drugs being used in this study 
Key Eligibility: 
  • Women and men age 18 and older
  • Pathologically confirmed diagnosis of chronic lymphocytic leukemia (CLL) 
  • Have received at least one prior therapy for CLL 
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020224

ClinicalTrials.gov:

NCT03801525

Sponsor:

U2-VEN-207

Status

Open to Enrollment

Age Group

Adult

Sponsor