Status:
TERMINATED
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
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ar...
Detailed Description
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 participants with CLL, who fa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04016805
Start Date
August 5 2019
End Date
May 22 2022
Last Update
July 24 2023
Active Locations (3)
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1
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States, 02114
2
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States, 07601
3
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10065