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Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

NCT02793583

Description:

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab with or without bendamustine and TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or that has not responded to standard treatment.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma
  • Official Title: A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma

Clinical Trial IDs

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

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DrugSynonymsArms
TGR-1202 + UblituximabTGR-1202 + Ublituximab
TGR-1202TGR-1202

Purpose

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab compared to TGR-1202 alone as a possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come back or that has not responded to standard treatment.

Trial Arms

NameTypeDescriptionInterventions
TGR-1202 + UblituximabExperimentalTGR-1202 oral daily dose in combination with Ublituximab intravenous administration
  • TGR-1202 + Ublituximab
TGR-1202ExperimentalTGR-1202 oral daily dose
  • TGR-1202

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Diffuse Large B-Cell Lymphoma

          -  Relapsed or refractory to prior standard therapy and subjects who are not candidates
             for high-dose therapy or autologous stem cell transplant

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        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 3 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.

Last Updated

April 5, 2017