IRB #

STUDY00015747

Title

A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Leukemia (CLL)

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of this study is to see how effective the combination of two investigational drugs (ublituximab and TGR-1202) are in comparison to the combination of two FDA approved drugs (obinutuzumab and chlorambucil) as well as in comparison to ublituximab and TGR-1202 when used alone, when given to people with chronic lymphocytic leukemia (CLL).

Medical Condition(s)

Chronic lymphocytic leukemia (CLL)

Eligibility Criteria

- Men and women at least 18 years of age
- Diagnosed with CLL
- No cancer therapy within 21 days of starting this study
- No prior treatment with idelalisib, duvelisib, ACP-319, obinutuzumab, or chlorambucil
- Women must not be pregnant

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

The study will involve about 15 visits or more to the study site. The time you will spend in the study and the number of visits will depend on the number of days you stay on the study. After you finish the study treatment, the study investigator will continue to watch you for side effects and follow your condition long-term.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

TG Therapeutics, Inc.

Recruitment End

01/01/2020

Compensation Provided

No


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