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Trial record 1 of 2 for:    UTX-TGR-304
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An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

This study is currently recruiting participants.
Verified September 2017 by TG Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02656303
First Posted: January 14, 2016
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
  Purpose
This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304

Condition Intervention Phase
Chronic Lymphocytic Leukemia Biological: ublituximab Drug: TGR-1202 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Every 12 weeks up to 2 years ]
    To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202


Estimated Enrollment: 300
Study Start Date: January 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ublituximab + TGR-1202
Ublituximab IV treatment + TGR-1202 oral daily dose
Biological: ublituximab
ublituximab IV infusion
Other Name: TG-1101
Drug: TGR-1202
TGR-1202 oral daily dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior treatment in clinical trial UTX-TGR-304
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Patients refractory to ublituximab + TGR-1202
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656303


Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, Arkansas
TG Therapeutics Investigational Trial Site Recruiting
Fayetteville, Arkansas, United States, 72703
Sponsors and Collaborators
TG Therapeutics, Inc.
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02656303     History of Changes
Other Study ID Numbers: UTX-TGR-204
First Submitted: January 13, 2016
First Posted: January 14, 2016
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell