Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab with or without bendamustine and TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or that has not responded to standard treatment.

Inclusion Criteria

• Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
• Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
• Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
• Prior therapy with a PI3K delta inhibitor

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
TG Therapeutics Inc

• Primary ID UTX-TGR-205
• Secondary IDs NCI-2016-01433
• Clinicaltrials.gov ID NCT02793583