Ublituximab + Ibrutinib in Select B-cell Malignancies

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02013128
Collaborator
(none)
66
18
1
22.8
3.7
0.2

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 6, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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 Names:
  • Ibrutinib (IMBRUVICA)
  • Outcome Measures

    Primary Outcome Measures

    1. To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Huntsville Alabama United States 35805
    2 TG Therapeutics Investigational Trial Site Tucson Arizona United States 85710
    3 TG Therapeutics Investigational Trial Site Santa Barbara California United States 93105
    4 TG Therapeutics Investigational Trial Site Boulder Colorado United States 80303
    5 TG Therapeutics Investigational Trial Site Niles Illinois United States 60714
    6 TG Therapeutics Investigational Trial Site Urbana Illinois United States 61801
    7 TG Therapeutics Investigational Trial Site Bethesda Maryland United States 20817
    8 TG Therapeutics Investigational Trial Site Morristown New Jersey United States 07962
    9 TG Therapeutics Investigational Trial Site Portland Oregon United States 97213
    10 TG Therapeutics Investigational Trial Site Springfield Oregon United States 97477
    11 TG Therapeutics Investigational Trial Site Greenville South Carolina United States 29615
    12 TG Therapeutics Investigational Trial Site Memphis Tennessee United States 38120
    13 TG Therapeutics Investigational Trial Site Austin Texas United States 78705
    14 TG Therapeutics Investigational Trial Site Dallas Texas United States 75230
    15 TG Therapeutics Investigational Trial Site Tyler Texas United States 75702
    16 TG Therapeutics Investigational Trial Site Blacksburg Virginia United States 24060
    17 TG Therapeutics Investigational Trial Site Fairfax Virginia United States 22031
    18 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02013128
    Other Study ID Numbers:
    • UTX-IB-104
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    Oct 2, 2019
    Last Verified:
    Oct 1, 2019

    Study Results

    No Results Posted as of Oct 2, 2019