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An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

NCT02656303

Description:

This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Enrolling by invitation

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
  • Official Title: A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

Clinical Trial IDs

  • ORG STUDY ID: UTX-TGR-204
  • NCT ID: NCT02656303

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
ublituximabTG-1101Ublituximab + TGR-1202
TGR-1202Ublituximab + TGR-1202

Purpose

This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304

Trial Arms

NameTypeDescriptionInterventions
Ublituximab + TGR-1202ExperimentalUblituximab IV treatment + TGR-1202 oral daily dose
  • ublituximab
  • TGR-1202

Eligibility Criteria

        Inclusion Criteria:

          -  Prior treatment in clinical trial UTX-TGR-304

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

        Exclusion Criteria:

          -  Patients refractory to ublituximab + TGR-1202

          -  Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
             transformation)
      
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 12 weeks up to 2 years
Safety Issue:
Description:To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Enrolling by invitation
Lead Sponsor:TG Therapeutics, Inc.

Last Updated

January 6, 2020