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Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Trial Status: Active

Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in subjects with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Inclusion Criteria

  • Subjects with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months
  • Minimal Residual Disease positive at screening
  • 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.
  • Subjects with a known histological transformation
  • Active Hepatitis B or Hepatitis C.

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

This is a Phase 2 open label, two treatment cohort trial evaluating the addition of

ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in

subjects with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with

ibrutinib, alacabrutinib or venetoclax.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
TG Therapeutics Inc

  • Primary ID UTX-TGR-208
  • Secondary IDs NCI-2019-06447
  • Clinicaltrials.gov ID NCT04016805