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

Trial Status: Active

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

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.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Amitkumar N. Mehta
Phone: 205-996-8400

California

Duarte
City of Hope Comprehensive Cancer Center
Status: IN_REVIEW
San Diego
University of California San Diego
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Sherri Miller
Phone: 913-945-7658

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

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 Phase II

Trial Type Treatment

Lead Organization
TG Therapeutics Inc

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