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)

• ClinicalTrials.gov Identifier: NCT02793583
• Recruitment Status: Recruiting
• First Posted: June 8, 2016
• Last Update Posted: March 5, 2021
• Sponsor: TG Therapeutics, Inc.
• Information provided by (Responsible Party): TG Therapeutics, Inc.

Tracking Information

• First Submitted Date: May 23, 2016
• First Posted Date: June 8, 2016
• Last Update Posted Date: March 5, 2021
• Actual Study Start Date: May 25, 2016
• Estimated Primary Completion Date: May 1, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2016): Overall Response Rate [ Time Frame: Every 8-12 weeks, up to 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 3, 2016): Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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
• 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 Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Biological: Ublituximab
  Other Name: TG-1101
• Drug: Umbralisib
  Other Name: TGR-1202
• Biological: Bendamustine
  Other Name: Treanda

Study Arms

• Experimental: Umbralisib + Ublituximab
  Umbralisib oral daily dose in combination with Ublituximab intravenous administration
  Interventions:

  • Biological: Ublituximab
  • Drug: Umbralisib
• Experimental: Umbralisib
  Umbralisib oral daily dose
  Intervention: Drug: Umbralisib
• Experimental: Umbralisib + Ublituximab + Bendamustine
  Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
  Interventions:

  • Biological: Ublituximab
  • Drug: Umbralisib
  • Biological: Bendamustine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 10, 2019): 900
• Original Estimated Enrollment (submitted: June 3, 2016): 200
• Estimated Study Completion Date: July 1, 2025
• Estimated Primary Completion Date: May 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: TG Therapeutics Clinical Support Team; 212-554-4279; clinicalsupport@tgtxinc.com

• Listed Location Countries: Australia, Israel, Italy, Korea, Republic of, Poland, Slovakia, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT02793583
• Other Study ID Numbers: UTX-TGR-205
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data will be shared once the last patient visit has been completed

• Responsible Party: TG Therapeutics, Inc.
• Study Sponsor: TG Therapeutics, Inc.
• Collaborators: Not Provided

Investigators

• Study Chair: Owen A O'Connor, MD, PhD; Columbia University

• PRS Account: TG Therapeutics, Inc.
• Verification Date: March 2021