Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: TG-1501 + Ublituximab + Umbralisib 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 |
Drug: Umbralisib
A once daily oral agent
Other Names:
Biological: ublituximab
IV anti-CD20 monoclonal antibody
Other Names:
Biological: TG-1501
IV immunotherapy for cancer
|
Outcome Measures
Primary Outcome Measures
- Determine Acceptable Adverse Events That Are Related to Treatment [6 months of therapy]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary Outcome Measures
- Overall Response Rate [Up to 1 year]
The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy
Eligibility Criteria
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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | TG Therapeutics Investigational Trial Site | New York | New York | United States | 10065 |
2 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27710 |
3 | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | United States | 19104 |
4 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- TG Therapeutics, Inc.
- Memorial Sloan Kettering Cancer Center
Investigators
- Study Chair: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TG-UPCC-108