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NCT02535286 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02535286
Other study ID # TG-UPCC-108
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 18, 2015
Est. completion date November 4, 2021

Study information
Verified date October 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date November 4, 2021
Est. primary completion date November 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Umbralisib
A once daily oral agent
Biological:
• ublituximab
IV anti-CD20 monoclonal antibody
• TG-1501
IV immunotherapy for cancer

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Durham North Carolina
United States TG Therapeutics Investigational Trial Site New York New York
United States TG Therapeutics Investigational Trial Site Philadelphia Pennsylvania
United States TG Therapeutics Investigational Trial Site Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
TG Therapeutics, Inc. Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine Acceptable Adverse Events That Are Related to Treatment To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities 6 months of therapy
Secondary Overall Response Rate The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy Up to 1 year
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