Clinical Trials /

Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naïve Follicular Lymphoma

NCT03828448

Description:

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

Related Conditions:
  • Follicular Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naïve Follicular Lymphoma
  • Official Title: A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: UTX-TGR-203
  • NCT ID: NCT03828448

Conditions

  • Follicular Lymphoma
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
UblituximabTG-1101ublituximab + umbralisib
UmbralisibTGR-1202ublituximab + umbralisib

Purpose

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

Detailed Description

      The study will assess the safety and efficacy of umbralisib in combination with ublituximab
      in subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma
      (SLL). Ublituximab will be administered through Cycle 12, while umbralisib will be
      administered through cycle 24. After this time, subjects will be followed for PFS.
    

Trial Arms

NameTypeDescriptionInterventions
ublituximab + umbralisibExperimentalUblituximab: 900 mg administered through Cycle 12, via IV infusion Umbralisib: 800 mg administered through Cycle 24, via daily oral tablet
  • Ublituximab
  • Umbralisib

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of Follicular Lymphoma (FL) or Small Lymphocytic Lymphoma (SLL).

          -  Measurable disease that requires treatment

          -  ECOG performance status ≤ 1

        Exclusion Criteria:

          -  Currently or previously received treatment for their lymphoma

          -  Received wide field radiotherapy within 28 days or limited field radiation within 14
             days of Cycle 1 Day 1

          -  Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
      
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:Up to 24 months
Safety Issue:
Description:The sum of patients with partial responses and complete responses

Secondary Outcome Measures

Measure:Progression-Free Survival
Time Frame:From date of randomization to the date of first documented progression assessed up to 4 years
Safety Issue:
Description:
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:12 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • Treatment naïve

Last Updated

January 6, 2020