Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma (UNITY-DLBCL)

PI: Troy H. Guthrie, Jr.

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab compared to TGR-1202 alone as a possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come

Disease

  • Lymphoma

Contact

North Florida / Jacksonville: Rhonda Calhoun (904) 427-1217

Topics

  • Lymphoma

Sponsors

TG Therapeutics, Inc.

Number

UTX-TGR-205

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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