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

October 19, 2022 updated by: TG Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Seattle, Washington, United States, 98109
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TG-1501 + Ublituximab + Umbralisib
Ublituximab 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
Drug: Umbralisib
A once daily oral agent
Other Names:
  • TGR-1202
Biological: ublituximab
IV anti-CD20 monoclonal antibody
Other Names:
  • TG-1101
Biological: TG-1501
IV immunotherapy for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine Acceptable Adverse Events That Are Related to Treatment
Time Frame: 6 months of therapy
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
6 months of therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

  • Study Chair: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2015

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-UPCC-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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