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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT04016805

Recruitment Status:

Active, not recruiting

Sponsor:

TG Therapeutics, Inc.

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There are 3 Locations for this study

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TG Therapeutics Investigational Trial Site
Boston Massachusetts, 02114, United States
TG Therapeutics Investigational Trial Site
Hackensack New Jersey, 07601, United States
TG Therapeutics Investigational Trial Site
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT04016805

Recruitment Status:

Active, not recruiting

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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