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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Tran

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.

Detailed Summary:
Sponsor: TG Therapeutics, Inc.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Overall Response Rate [ Time Frame: Up to 1 year ]

The overall response rate (ORR) in patients with CLL treated with Ublituximab in combination with TGR-1202 and Pembrolizumab


Information By: TG Therapeutics, Inc.

Dates:
Date Received: August 24, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: April 7, 2017
Last Verified: April 2017