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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Acalabrutinib; Antibodies, Monoclonal; Venetoclax

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.