Chronic Lymphocytic Leukemia Clinical Trial
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
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 (leukemia-cll/" >CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
Full 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 subjects with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.
Eligibility 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.
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There are 3 Locations for this study
Boston Massachusetts, 02114, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
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