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

This study is currently recruiting participants.
Verified September 2017 by TG Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02006485
First Posted: December 10, 2013
Last Update Posted: September 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 140
Study Start Date: December 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, Arkansas
TG Therapeutics Investigational Trial Site Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
TG Therapeutics Investigational Trial Site Recruiting
Duarte, California, United States, 91010
United States, Georgia
TG Therapeutics Investigational Trial Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Nebraska
TG Therapeutics Investigational Trial Site Recruiting
Omaha, Nebraska, United States, 68198
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: TG Therapeutics Trial Site    212-554-4484    clinicalsupport@tgtxinc.com   
Principal Investigator: Nathan Fowler, MD         
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Nathan Fowler, MD M.D. Anderson Cancer Center
Study Chair: Susan O'Brien, MD University of California Irvine Cancer Center
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02006485     History of Changes
Other Study ID Numbers: UTX-TGR-103
First Submitted: December 5, 2013
First Posted: December 10, 2013
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents