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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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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

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

Intervention / Treatment
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* Biological: Ublituximab
* Drug: Umbralisib
* Biological: Bendamustine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbralisib + Ublituximab<br>Umbralisib oral daily dose in combination with Ublituximab intravenous administration | Biological: Ublituximab<br> <br> * Other names: TG-1101;Drug: Umbralisib<br> <br> * Other names: TGR-1202;|
| Experimental: Umbralisib<br>Umbralisib oral daily dose | Drug: Umbralisib<br> <br> * Other names: TGR-1202;|
| Experimental: Umbralisib + Ublituximab + Bendamustine<br>Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration | Biological: Ublituximab<br> <br> * Other names: TG-1101;Drug: Umbralisib<br> <br> * Other names: TGR-1202;Biological: Bendamustine<br> <br> * Other names: Treanda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | Every 8-12 weeks, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | From date of randomization until the date of first documented progression, assessed up through 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FL, DLBCL, MZL, MCL, SLL, Non-Hodgkin's Lymphoma