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Ublituximab + Ibrutinib in Select B-cell Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02013128
First received: December 11, 2013
Last updated: September 7, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Drug: Ublituximab Drug: Ibrutinib Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 62
Study Start Date: December 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013128

Locations
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
Study Chair: Jeff Sharman, MD Willamette Valley Cancer Institute
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02013128     History of Changes
Other Study ID Numbers: UTX-IB-104
Study First Received: December 11, 2013
Last Updated: September 7, 2017

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 21, 2017