Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter’s Transformation

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Brief Title

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Official Title

Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

Brief Summary

      The purpose of this study is to evaluate the safety and effectiveness of targeted
      immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL
      or Richter's Transformation.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Determine Acceptable Adverse Events That Are Related to Treatment

Secondary Outcome

 Overall Response Rate

Condition

Chronic Lymphocytic Leukemia

Intervention

Umbralisib

Study Arms / Comparison Groups

 TG-1501 + Ublituximab + Umbralisib
Description:  Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals

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

27

Start Date

September 18, 2015

Completion Date

November 4, 2021

Primary Completion Date

November 4, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation

          -  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 14 days

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

          -  Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anthony R. Mato, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02535286

Organization ID

TG-UPCC-108


Responsible Party

Sponsor

Study Sponsor

TG Therapeutics, Inc.

Collaborators

 Memorial Sloan Kettering Cancer Center

Study Sponsor

Anthony R. Mato, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

December 2021