Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring umbralisib, ublituximab, venetoclax, ibrutinib, CLL, acalabrutinib
Eligibility Criteria
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.
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
ublituximab + umbralisib + ibrutinib
ublituximab + umbralisib + venetoclax
ublituximab + umbralisib + acalabrutinib
Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; ibrutinib oral tablet daily (1 Cycle = 28 days).
Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; venetoclax oral tablet daily (1 Cycle = 28 days).
Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; acalabrutinib oral capsule every 12 hours (1 Cycle = 28 days).