Clinical Trials /

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

NCT02535286

Description:

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Richter Syndrome
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02535286

Trial Eligibility

Document

Title

  • Brief Title: Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
  • Official Title: Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

Clinical Trial IDs

  • ORG STUDY ID: TG-UPCC-108
  • NCT ID: NCT02535286

Conditions

  • Chronic Lymphocytic Leukemia
  • Richter Syndrome

Interventions

DrugSynonymsArms
UmbralisibTGR-1202TG-1501 + Ublituximab + Umbralisib
ublituximabTG-1101TG-1501 + Ublituximab + Umbralisib
TG-1501TG-1501 + Ublituximab + Umbralisib

Purpose

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Trial Arms

NameTypeDescriptionInterventions
TG-1501 + Ublituximab + UmbralisibExperimentalUblituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
  • Umbralisib
  • ublituximab
  • TG-1501

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation

          -  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 14 days

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

          -  Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
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:6 months of therapy
Safety Issue:
Description:To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:Up to 1 year
Safety Issue:
Description:The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:TG Therapeutics, Inc.

Last Updated

August 23, 2021