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Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

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: NCT02535286
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Richter Syndrome Drug: Umbralisib Biological: ublituximab Biological: TG-1501 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
Actual Study Start Date : September 18, 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TG-1501 + Ublituximab + Umbralisib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
Drug: Umbralisib
A once daily oral agent
Other Name: TGR-1202

Biological: ublituximab
IV anti-CD20 monoclonal antibody
Other Name: TG-1101

Biological: TG-1501
IV immunotherapy for cancer




Primary Outcome Measures :
  1. Determine Acceptable Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 1 year ]
    The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy



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:

  • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
  • 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 14 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

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): NCT02535286


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

Locations
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United States, New York
TG Therapeutics Investigational Trial Site Recruiting
New York, New York, United States, 10065
United States, North Carolina
TG Therapeutics Investigational Trial Site Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennyslvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Teresa Waite, RN       Terese.Waite@uphs.upenn.edu   
Contact: Tanya Latorre, RN       tanya.latorre@uphs.upenn.edu   
United States, Washington
TG Therapeutics Clinical Support Team Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
TG Therapeutics, Inc.
Memorial Sloan Kettering Cancer Center
Investigators
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Study Chair: Anthony R. Mato, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02535286    
Other Study ID Numbers: TG-UPCC-108
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell