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

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Key facts

Study ID

NCT04016805

Run by

TG Therapeutics, Inc.

People needed

41

Starts

2019-08-05

Expected to finish

2022-05-22

Last updated by the study team

2023-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants 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.

You may not qualify if…

• Participants receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1.
• Participants with a known histological transformation
• Active Hepatitis B or Hepatitis C.

Where it is running

• TG Therapeutics Investigational Trial Site — Boston, Massachusetts, United States
• TG Therapeutics Investigational Trial Site — Hackensack, New Jersey, United States
• TG Therapeutics Investigational Trial Site — New York, New York, United States

Full record on ClinicalTrials.gov

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