Clinical Trial: NCT02793583 - My Cancer Genome

NCT02793583

Description:

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

Related Conditions:

Non-Hodgkin Lymphoma

Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

URL:

https://clinicaltrials.gov/show/NCT02793583

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: UTX-TGR-205
NCT ID: NCT02793583

Conditions

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

Interventions

Drug	Synonyms	Arms
Ublituximab	TG-1101	Umbralisib + Ublituximab
Umbralisib	TGR-1202	Umbralisib
Bendamustine	Treanda	Umbralisib + Ublituximab + Bendamustine

Purpose

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).

Trial Arms

Name	Type	Description	Interventions
Umbralisib + Ublituximab	Experimental	Umbralisib oral daily dose in combination with Ublituximab intravenous administration	Ublituximab Umbralisib
Umbralisib	Experimental	Umbralisib oral daily dose	Umbralisib
Umbralisib + Ublituximab + Bendamustine	Experimental	Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration	Ublituximab Umbralisib Bendamustine

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Overall Response Rate
Time Frame:	Every 8-12 weeks, up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:	Phase 2/Phase 3
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	TG Therapeutics, Inc.

Trial Keywords

DLBCL
FL
MZL
MCL
SLL
Non-Hodgkin's Lymphoma

Last Updated

August 23, 2021

Clinical Trials /

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