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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 : April 11, 2017
Information provided by (Responsible Party):

Study Description
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 Design

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 2017
Estimated Study Completion Date : December 2017

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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)
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): NCT02535286

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

United States, Pennsylvania
University of Pennyslvania Center for CLL Recruiting
Philadelphia, Pennsylvania, United States, 19146
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
Study Chair: Anthony R. Mato, MD University of Pennsylvania Center for CLL
More Information

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: April 11, 2017
Last Verified: April 2017

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