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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

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ClinicalTrials.gov Identifier: NCT02656303
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2016
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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)
Contacts and Locations
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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


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Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02656303     History of Changes
Other Study ID Numbers: UTX-TGR-204
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs