Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207256
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2017
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma Drug: TGR-1202 Drug: TGR-1202 + Ublituximab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Compassionate Use Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials With B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03207256


Locations
Layout table for location information
United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States, 85711
United States, Arkansas
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States, 72703
United States, California
TG Therapeutics Investigational Trial Site
Duarte, California, United States, 91010
United States, Florida
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States, 33901
United States, Georgia
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, United States, 30322
United States, Indiana
TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana, United States, 46804
United States, Minnesota
TG Therapeutics Investigational Trial Site
Coon Rapids, Minnesota, United States, 55433
United States, Nebraska
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, United States, 68198
United States, North Carolina
TG Therapeutics Investigational Trial Site
Durham, North Carolina, United States, 27710
United States, Ohio
TG Therapeutics Investigational Site
Canton, Ohio, United States, 44718
TG Therapeutics Investigational Trial Site
Cincinnati, Ohio, United States, 45242
United States, Tennessee
TG Therapeutics Investigational Trial Site
Germantown, Tennessee, United States, 38138
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States, 37203
United States, Texas
TG Therapeutics Investigational Trial Site
Denton, Texas, United States, 76210
TG Therapeutics Investigational Trial Site
San Antonio, Texas, United States, 78229
United States, Wisconsin
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
TG Therapeutics, Inc.

Layout table for additonal information
Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03207256    
Other Study ID Numbers: UTX-TGR-501
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs