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

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

Inclusion Criteria

• Diagnosis of Non-Hodgkin's Lymphoma including 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
• MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

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

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy

and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to

also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL,

SLL, MZL, DLBCL and MCL).

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