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Ublituximab + Ibrutinib in Select 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: NCT02013128
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : October 24, 2022
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 Ibrutinib in patients with advanced hematologic malignancies.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Drug: Ublituximab Drug: Ibrutinib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Actual Study Start Date : January 6, 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ublituximab + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
 Drug: Ublituximab
Ublituximab (IV infusion)

Drug: Ibrutinib
Ibrutinib oral daily dose
Other Name: Ibrutinib (IMBRUVICA)


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies [ 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 Ibrutinib


Eligibility Criteria
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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:

  • Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
  • 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. Prior Allogeneic hematologic stem cell transplant is excluded.
  • Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
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): NCT02013128


Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arizona
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States, 85710
United States, California
TG Therapeutics Investigational Trial Site
Santa Barbara, California, United States, 93105
United States, Colorado
TG Therapeutics Investigational Trial Site
Boulder, Colorado, United States, 80303
United States, Illinois
TG Therapeutics Investigational Trial Site
Niles, Illinois, United States, 60714
TG Therapeutics Investigational Trial Site
Urbana, Illinois, United States, 61801
United States, Maryland
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States, 20817
United States, New Jersey
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, United States, 07962
United States, Oregon
TG Therapeutics Investigational Trial Site
Portland, Oregon, United States, 97213
TG Therapeutics Investigational Trial Site
Springfield, Oregon, United States, 97477
United States, South Carolina
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, United States, 38120
United States, Texas
TG Therapeutics Investigational Trial Site
Austin, Texas, United States, 78705
TG Therapeutics Investigational Trial Site
Dallas, Texas, United States, 75230
TG Therapeutics Investigational Trial Site
Tyler, Texas, United States, 75702
United States, Virginia
TG Therapeutics Investigational Trial Site
Blacksburg, Virginia, United States, 24060
TG Therapeutics Investigational Trial Site
Fairfax, Virginia, United States, 22031
United States, Washington
TG Therapeutics Investigational Trial Site
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Jeff Sharman, MD Willamette Valley Cancer Institute
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02013128    
Other Study ID Numbers: UTX-IB-104
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
Lymphoma, Non-Hodgkin
Lymphoma