SHS_492372 PAGJ CTGT 17030

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma.

Inclusion Criteria:

• Diagnosis of Diffuse Large B-Cell 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 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded

• Prior therapy with a PI3K delta inhibitor
Phase II/III
NCT02793583
Cancer
Hematologic
John Pagel, M.D.
TG Therapeutics, Inc.
Ngan Trinh
  • Swedish Medical Center