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Trial record 1 of 2 for:    TG1501
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Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT03778073
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
Phase 1 open label, single-arm, multi-center, dose-escalation study for individuals with relapsed or refractory classical Hodgkin's Lymphoma or B-cell Non Hodgkin's Lymphoma.

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma B-cell Non Hodgkin Lymphoma Drug: TG-1501 Phase 1

Detailed Description:
Planned enrollment includes 3 subjects at each dose level. TG-1501 will be administered as a 60-minute IV infusion at fixed dose levels on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: TG-1501
TG-1501 will be administered as a 60-minute intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle.
Drug: TG-1501
Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle




Primary Outcome Measures :
  1. Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 12 months ]
    Objective response in subjects treated with TG-1501



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.


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

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL) or B-cell non-Hodgkin lymphoma (NHL).
  • Measurable disease and adequate organ function as specified in the protocol
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
  • Prior autologous stem cell transplant within 3 months
  • Active Hepatitis B or Hepatitis C

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): NCT03778073


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

Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site Recruiting
Tucson, Arizona, United States, 85711
United States, Arkansas
TG Therapeutics Investigational Trial Site Recruiting
Fayetteville, Arkansas, United States, 72703
United States, Illinois
TG Therapeutics Investigational Trial Site Recruiting
Peoria, Illinois, United States, 61615
United States, Indiana
TG Therapeutics Investigational Trial Site Recruiting
Fort Wayne, Indiana, United States, 46804
United States, Kansas
TG Therapeutics Investigational Trial Site Recruiting
Fairway, Kansas, United States, 64154
United States, Kentucky
TG Therapeutics Investigational Trial Site Recruiting
Louisville, Kentucky, United States, 40207
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28262
Contact: clinicalsupport@tgtxinc.com         
United States, Washington
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03778073    
Other Study ID Numbers: TG-1501-101
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TG Therapeutics, Inc.:
relapsed or refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin