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)

TG Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; Follicular Lymphoma; Diffuse Large B-Cell Lymphoma

Treatments: Biological: Ublituximab; Drug: Umbralisib; Biological: Bendamustine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02793583

UTX-TGR-205

Details and patient eligibility

About

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

Full description

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).

Enrollment: 710 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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710 participants in 3 patient groups

Umbralisib + Ublituximab

Experimental group

Description:

Umbralisib oral daily dose in combination with Ublituximab intravenous administration

Treatment:

Drug: Umbralisib

Biological: Ublituximab

Umbralisib

Experimental group

Description:

Umbralisib oral daily dose

Treatment:

Drug: Umbralisib

Umbralisib + Ublituximab + Bendamustine

Experimental group

Description:

Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

Treatment:

Biological: Bendamustine

Drug: Umbralisib

Biological: Ublituximab