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

Phase 2

Terminated

• Conditions: Marginal Zone Lymphoma; Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma
• Interventions: Biological: Ublituximab; Drug: Umbralisib; Biological: Bendamustine

• Registration Number: NCT02793583
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2016-05-23
• Study Start: 2016-05-25
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Primary Completion: 2022-05-31
• Status Verified: 2022-07
• Study Completion: 2022-07-04
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 710

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbralisib + Ublituximab	Ublituximab	Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Umbralisib + Ublituximab	Umbralisib	Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Umbralisib	Umbralisib	Umbralisib oral daily dose
Umbralisib + Ublituximab + Bendamustine	Ublituximab	Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Umbralisib + Ublituximab + Bendamustine	Umbralisib	Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Umbralisib + Ublituximab + Bendamustine	Bendamustine	Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	Every 8-12 weeks, up to 2 years

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	From date of randomization until the date of first documented progression, assessed up through 2 years

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇬🇧 Plymouth, United Kingdom