Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL

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Richter syndrome
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Brief Title

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Official Title

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Brief Summary

      Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib
      in Subjects with Relapsed or Refractory CLL/SLL and NHL

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Determine Acceptable Adverse Events That Are Related to Treatment

Secondary Outcome

 Overall Response and Complete Remission Rate

Condition

Chronic Lymphocytic Leukemia

Intervention

Venetoclax

Study Arms / Comparison Groups

 Ublituximab + Umbralisib + Venetoclax
Description:  Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

150

Start Date

March 27, 2018

Completion Date

March 1, 2023

Primary Completion Date

January 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma

          -  Refractory to or relapsed after at least 1 prior treatment regimen

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Any major surgery, chemotherapy or immunotherapy within the last 21 days

          -  Known hepatitis B virus, hepatitis C virus or HIV infection

          -  Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Paul Barr, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03379051

Organization ID

U2-VEN-109

Responsible Party

Sponsor

Study Sponsor

TG Therapeutics, Inc.

Collaborators

 James P. Wilmot Cancer Center

Study Sponsor

Paul Barr, MD, Study Chair, Wilmot Cancer Institute - University of Rochester

Verification Date

May 2022