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An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656303
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2016
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 13, 2016
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE January 7, 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Overall Response Rate [ Time Frame: Every 12 weeks up to 2 years ]
To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02656303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
Official Title  ICMJE A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
Brief Summary This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Biological: ublituximab
    ublituximab IV infusion
    Other Name: TG-1101
  • Drug: TGR-1202
    TGR-1202 oral daily dose
Study Arms  ICMJE Experimental: Ublituximab + TGR-1202
Ublituximab IV treatment + TGR-1202 oral daily dose
Interventions:
  • Biological: ublituximab
  • Drug: TGR-1202
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prior treatment in clinical trial UTX-TGR-304
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Patients refractory to ublituximab + TGR-1202
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656303
Other Study ID Numbers  ICMJE UTX-TGR-204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP