Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

November 16, 2022 updated by: TG Therapeutics, Inc.

An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy

The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • TG Therapeutics Investigational Trial Site
      • Macon, Georgia, United States, 31201
        • 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
    • New York
      • New York, New York, United States, 10022
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • 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:

  • Relapsed or Refractory B-cell Lymphoma
  • Measurable or Evaluable Disease
  • Previously treated with at least one line of rituximab or a rituximab based therapy
  • Patients ineligible for high dose or combination chemotherapy + stem cell transplant
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology

Exclusion Criteria:

  • Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
  • Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
  • History of severe hypersensitivity or anaphylaxis to prior rituximab
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
  • Pregnant women

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

Phase I:

4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 & 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply.
Drug: Ublituximab
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Subjects will be followed for 4 weeks
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Subjects will be followed for 4 weeks
Maximum Tolerated Dose acceptable for participants
Time Frame: Subjects will be followed for 4 weeks
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Subjects will be followed for 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Participants will be evaluated approximately every 8 - 12 weeks
Efficacy will include overall response rate, duration of response and progression-free survival
Participants will be evaluated approximately every 8 - 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile including Peak Plasma Concentration (Cmax)" or "Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC)
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

Investigators

  • Study Director: TG Therapeutics Clinical Trials, 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)

July 19, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGTX 1101-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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