Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib or Venetoclax
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 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.
Locations & Contacts
Name Not Available
Trial Objectives and Outline
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 or venetoclax.
Trial Phase & Type
TG Therapeutics Inc
Secondary IDs NCI-2019-06447
Clinicaltrials.gov ID NCT04016805