Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

July 20, 2022 updated by: TG Therapeutics, Inc.

An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.

This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

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
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Tucson, Arizona, United States, 85711
        • TG Therapeutics Investigational Trial Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • TG Therapeutics Investigational Trial Site
    • California
      • Duarte, California, United States, 91010
        • TG Therapeutics Investigational Trial Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • TG Therapeutics Investigational Trial Site
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • TG Therapeutics Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Denton, Texas, United States, 76210
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, United States, 78229
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Seattle, Washington, United States, 98104
        • TG Therapeutics Investigational Trial Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
  • Subjects must have completed at least 6 cycles of therapy on their current protocol.

Exclusion Criteria:

  • Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TGR-1202
Oral TGR-1202 Daily
Drug: TGR-1202
Oral Daily TGR-1202
Experimental: TGR-1202 + Ublituximab
Oral TGR-1202 in combination with Ublituximab intravenous administration
Drug: TGR-1202 + Ublituximab
Oral Daily TGR-1202 + Ublituximab IV Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
Time Frame: Evaluated at each planned visit through study completion, an average of 2 years
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
Evaluated at each planned visit through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
Time Frame: Evaluated at each planned visit through study completion, an average of 2 years
Date of progression reported for each patient
Evaluated at each planned visit through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

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)

August 9, 2017

Primary Completion (Actual)

May 25, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTX-TGR-501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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