Ublituximab + Ibrutinib in Select B-cell Malignancies

October 21, 2022 updated by: TG Therapeutics, Inc.

A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • 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
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • TG Therapeutics Investigational Trial Site
    • California
      • Santa Barbara, California, United States, 93105
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Boulder, Colorado, United States, 80303
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Niles, Illinois, United States, 60714
        • TG Therapeutics Investigational Trial Site
      • Urbana, Illinois, United States, 61801
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • TG Therapeutics Investigational Trial Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • TG Therapeutics Investigational Trial Site
      • Springfield, Oregon, United States, 97477
        • TG Therapeutics Investigational Trial Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Austin, Texas, United States, 78705
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, United States, 75230
        • TG Therapeutics Investigational Trial Site
      • Tyler, Texas, United States, 75702
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • TG Therapeutics Investigational Trial Site
      • Fairfax, Virginia, United States, 22031
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Vancouver, Washington, United States, 98684
        • 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 Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
  • 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
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
  • Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma

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: Ublituximab + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Drug: Ublituximab
Ublituximab (IV infusion)
Drug: Ibrutinib
Ibrutinib oral daily dose
Other Names:
  • Ibrutinib (IMBRUVICA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
Time Frame: 28 days (1 cycle of therapy)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
28 days (1 cycle of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 1 year
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib
Up to 1 year

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

Investigators

  • Study Chair: Jeff Sharman, MD, Willamette Valley Cancer Institute

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)

January 6, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTX-IB-104

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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