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
- 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.
- 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.
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
TG Therapeutics Inc
- Primary ID UTX-TGR-208
- Secondary IDs NCI-2019-06447
- Clinicaltrials.gov ID NCT04016805