Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

August 19, 2022 updated by: TG Therapeutics, Inc.
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • TG Therapeutics Investigational Trial Site
    • New York
      • Rochester, New York, United States, 14642
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • 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

14 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 Non-Hodgkin's Lymphoma
  • 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
  • Known histological transformation from CLL to an aggressive lymphoma (Richter's)

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ublituximab + Umbralisib + Venetoclax
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Drug: Venetoclax
BCL-2 Inhibitor
Other Names:
  • Venclexta
Drug: Umbralisib
PI3K-Delta Inhibitor
Other Names:
  • TGR-1202
Biological: Ublituximab
Glycoengineered Anti-CD20 mAb
Other Names:
  • TG-1101
Experimental: Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Drug: Umbralisib
PI3K-Delta Inhibitor
Other Names:
  • TGR-1202
Biological: Ublituximab
Glycoengineered Anti-CD20 mAb
Other Names:
  • TG-1101
Drug: Lenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Other Names:
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine Acceptable Adverse Events That Are Related to Treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response and Complete Remission Rate
Time Frame: 12 months
12 months
Minimum Residual Disease (MRD)
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

Collaborators

James P. Wilmot Cancer Center

Investigators

  • Study Chair: Paul Barr, MD, Wilmot Cancer Institute - University of Rochester

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)

March 27, 2018

Primary Completion (Actual)

May 26, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U2-VEN-109

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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