- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006485
Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies
November 4, 2019 updated by: TG Therapeutics, Inc.
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.
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
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35805
- TG Therapeutics Investigational Trial Site
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- TG Therapeutics Investigational Trial Site
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California
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Duarte, California, United States, 91010
- TG Therapeutics Investigational Trial Site
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Georgia
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Atlanta, Georgia, United States, 30322
- TG Therapeutics Investigational Trial Site
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Nebraska
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Omaha, Nebraska, United States, 68198
- TG Therapeutics Investigational Trial Site
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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Ublituximab IV infusion TGR-1202 oral daily dose
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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
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Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
Other Names:
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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
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Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose acceptable for participants
Time Frame: 28 days (1 cycle of therapy)
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To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
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28 days (1 cycle of therapy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: Up to 1 year
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To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202
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Up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nathan Fowler, MD, M.D. Anderson Cancer Center
- Study Chair: Susan O'Brien, MD, University of California Irvine Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S. Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2019 Nov 21;134(21):1811-1820. doi: 10.1182/blood.2019002118.
- Nastoupil LJ, Lunning MA, Vose JM, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Burger JA, Wierda WG, O'Brien S, Sportelli P, Miskin HP, Purdom MA, Weiss MS, Fowler NH. Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial. Lancet Haematol. 2019 Feb;6(2):e100-e109. doi: 10.1016/S2352-3026(18)30216-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2013
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Actual)
November 5, 2019
Last Update Submitted That Met QC Criteria
November 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Leukemia, Lymphocytic, Chronic, B-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Bendamustine Hydrochloride
- Antibodies, Monoclonal
Other Study ID Numbers
- UTX-TGR-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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