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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 : Terminated (Strategic/Business Decision)
First Posted : January 14, 2016
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 7, 2016
Actual Primary Completion Date : May 26, 2022
Actual Study Completion Date : July 11, 2022


Arm Intervention/treatment
Experimental: Ublituximab + TGR-1202
Ublituximab IV treatment + TGR-1202 oral daily dose
Biological: ublituximab
ublituximab IV infusion
Other Name: TG-1101

Drug: TGR-1202
TGR-1202 oral daily dose




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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:

  • 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)

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): NCT02656303


Locations
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Sponsors and Collaborators
TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02656303    
Other Study ID Numbers: UTX-TGR-204
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell