Clinical Trials /

Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL

NCT03379051

Description:

This study will be a standard 3+3 design with a lead in of umbralisib (TGR-1202) + ublituximab for 12 weeks, i.e. 3 cycles, followed by venetoclax (20 mg - 200 mg) along with umbralisib (TGR-1202) and ublituximab for patients with relapsed/refractory CLL.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL
  • Official Title: Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL

Clinical Trial IDs

  • ORG STUDY ID: U2-VEN-109
  • NCT ID: NCT03379051

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
VenetoclaxVenclextaUblituximab + Umbralisib + Venetoclax
UmbralisibTGR-1202Ublituximab + Umbralisib + Venetoclax
UblituximabTG-1101Ublituximab + Umbralisib + Venetoclax

Purpose

This study will be a standard 3+3 design with a lead in of umbralisib (TGR-1202) + ublituximab for 12 weeks, i.e. 3 cycles, followed by venetoclax (20 mg - 200 mg) along with umbralisib (TGR-1202) and ublituximab for patients with relapsed/refractory CLL.

Trial Arms

NameTypeDescriptionInterventions
Ublituximab + Umbralisib + VenetoclaxExperimentalUblituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
  • Venetoclax
  • Umbralisib
  • Ublituximab

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia

          -  Refractory to or relapsed after at least 1 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

          -  Known hepatitis B virus, hepatitis C virus or HIV infection

          -  Known histological transformation from CLL to an aggressive lymphoma (Richter's)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine Acceptable Adverse Events That Are Related to Treatment
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Complete Remission Rate
Time Frame:12 months
Safety Issue:
Description:
Measure:Minimum Residual Disease (MRD)
Time Frame:12 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:TG Therapeutics, Inc.

Last Updated

January 6, 2020