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Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma

NCT03364231

Description:

This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.

Related Conditions:
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma
  • Official Title: A Phase 2 Study to Assess the Efficacy and Safety of TGR-1202 (Umbralisib) Monotherapy in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: TGR-1202-202
  • NCT ID: NCT03364231

Conditions

  • Waldenstrom Macroglobulinemia

Interventions

DrugSynonymsArms
UmbralisibTGR-1202Umbralisib

Purpose

This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.

Trial Arms

NameTypeDescriptionInterventions
UmbralisibExperimentalUmbralisib oral daily dose
  • Umbralisib

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of Waldenstroms Macroglobulinemia

          -  Relapsed or refractory after at least one prior treatment regimen

          -  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

          -  Prior autologous stem cell transplant within 6 months of study entry
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
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:

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

Last Updated

January 6, 2020