A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.
Overview
- Phase
- Phase 1
- Intervention
- Ublituximab + TGR-1202
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Maximum Tolerated Dose acceptable for participants
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
- •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
- •Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
- •Primary central nervous system lymphoma or known intracranial involvement
Arms & Interventions
Ublituximab + TGR-1202
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
Intervention: Ublituximab + TGR-1202
Ublituximab + TGR-1202 + ibrutinib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
Intervention: Ublituximab + TGR-1202 + ibrutinib
Ublituximab + TGR-1202 + bendamustine
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 \& 2
Intervention: Ublituximab + TGR-1202 + bendamustine
Outcomes
Primary Outcomes
Maximum Tolerated Dose acceptable for participants
Time Frame: 28 days (1 cycle of therapy)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary Outcomes
- Overall Response Rate(Up to 1 year)