Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies
NCT ID: NCT02006485
Last Updated: 2019-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
160 participants
INTERVENTIONAL
2013-12-13
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ublituximab + TGR-1202
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
Ublituximab + TGR-1202
Ublituximab IV infusion TGR-1202 oral daily dose
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
Ublituximab + TGR-1202 + ibrutinib
Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
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
Ublituximab + TGR-1202 + bendamustine
Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
Interventions
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Ublituximab + TGR-1202
Ublituximab IV infusion TGR-1202 oral daily dose
Ublituximab + TGR-1202 + ibrutinib
Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
Ublituximab + TGR-1202 + bendamustine
Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Fowler, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Susan O'Brien, MD
Role: STUDY_CHAIR
University of California Irvine Cancer Center
Locations
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TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Jonesboro, Arkansas, United States
TG Therapeutics Investigational Trial Site
Duarte, California, United States
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, United States
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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UTX-TGR-103
Identifier Type: -
Identifier Source: org_study_id
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