A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 with or without Bendamustine and TGR-1202 alone in Patients with Previously Treated Non-Hodgkin’s Lymphoma

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

Inclusion Criteria:
Histologically confirmed diagnosis of: B-cell NHL with histological subtype limited to the following:
  a. Follicular Lymphoma (FL) of Grade 1, 2, or 3a;
  b. Marginal Zone Lymphoma (MZL) (splenic, nodal, or extranodal); or
  c. Mantle Cell Lymphoma (MCL) – with documentation of either overexpression of cyclin D1 or t(11;14).

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