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Study of Pembrolizumab in Combination With Ublituximab and TGR-1202 in Patients With Relapsed-refractory CLL or Richter's Transformation

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ClinicalTrials.gov Identifier: NCT02535286
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Abramson Cancer Center of the University of Pennsylvania
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of pembrolizumab in combination with ublituximab and TGR-1202, in patients with advanced CLL or Richter's Transformation.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Pembrolizumab Drug: TGR-1202 Biological: ublituximab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Pembrolizumab in Combination With TG-1101 (Ublituximab) and TGR-1202 in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT)
Study Start Date : September 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Pembrolizumab + Ublituximab + TGR-1202
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Pembrolizumab IV infusion at scheduled intervals
Drug: Pembrolizumab
IV immunotherapy for cancer
Other Name: Keytruda

Drug: TGR-1202
A once daily oral agent

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




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 TGR-1202 and Pembrolizumab



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

Locations
United States, New York
TG Therapeutics Investigational Trial Site Recruiting
New York, New York, United States, 10065
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.
Abramson Cancer Center of the University of Pennsylvania
Investigators
Study Chair: Anthony R. Mato, MD Memorial Sloan Kettering Cancer Center

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02535286     History of Changes
Other Study ID Numbers: TG-UPCC-108
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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
Pembrolizumab
Antineoplastic Agents