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Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

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: NCT02006485
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Non-Hodgkin's Lymphoma Drug: Ublituximab + TGR-1202 Drug: Ublituximab + TGR-1202 + ibrutinib Drug: Ublituximab + TGR-1202 + bendamustine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.
Actual Study Start Date : December 13, 2013
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ublituximab + TGR-1202
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
 Drug: Ublituximab + TGR-1202
Ublituximab IV infusion TGR-1202 oral daily dose
Experimental: Ublituximab + TGR-1202 + ibrutinib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
 Drug: Ublituximab + TGR-1202 + ibrutinib
Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
Other Name: Imbruvica
Experimental: Ublituximab + TGR-1202 + bendamustine
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 & 2
 Drug: Ublituximab + TGR-1202 + bendamustine
Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
Other Name: Treanda


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle 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 ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with 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:

  • Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
  • 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 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
  • Primary central nervous system lymphoma or known intracranial involvement
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): NCT02006485


Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arkansas
TG Therapeutics Investigational Trial Site
Jonesboro, Arkansas, United States, 72401
United States, California
TG Therapeutics Investigational Trial Site
Duarte, California, United States, 91010
United States, Georgia
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, United States, 30322
United States, Nebraska
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, United States, 68198
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Nathan Fowler, MD M.D. Anderson Cancer Center
Study Chair: Susan O'Brien, MD University of California Irvine Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02006485    
Other Study ID Numbers: UTX-TGR-103
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Chronic Disease
 Disease Attributes
Pathologic Processes
Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs