Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Overview
- Phase
- Phase 1
- Intervention
- Venetoclax
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Determine Acceptable Adverse Events That Are Related to Treatment
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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
Investigators
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)
Arms & Interventions
Ublituximab + Umbralisib + Venetoclax
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
Intervention: Venetoclax
Ublituximab + Umbralisib + Venetoclax
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
Intervention: Umbralisib
Ublituximab + Umbralisib + Venetoclax
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
Intervention: Ublituximab
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Intervention: Umbralisib
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Intervention: Ublituximab
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Intervention: Lenalidomide
Outcomes
Primary Outcomes
Determine Acceptable Adverse Events That Are Related to Treatment
Time Frame: 12 months
Secondary Outcomes
- Overall Response and Complete Remission Rate(12 months)
- Minimum Residual Disease (MRD)(12 months)