Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

ULTRA-V: Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Venetoclax

Criteria

Inclusion Criteria:

• Chronic Lymphocytic Leukemia (CLL) that warrants treatment

• 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.

• Prior exposure to any PI3K inhibitor or venetoclax

• Autologous hematologic stem cell transplant within 6 months of study entry. Prior. Allogeneic hematologic stem cell transplant is excluded.

• Active Hepatitis B or Hepatitis C.