Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    900
  • sponsor
    TG Therapeutics, Inc.
Updated on 22 September 2021
stem cell transplantation
lymphoma
hodgkin's disease
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
marginal zone lymphoma
large b-cell lymphoma
ibrutinib
bendamustine
btk inhibitor
acalabrutinib
umbralisib

Summary

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Description

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

Details
Condition Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, MALT Lymphoma, Mantle cell lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma
Treatment Bendamustine, TGR-1202, ublituximab, TGR-1202 + Ublituximab, TGR-1202 + Ublituximab + Bendamustine, Umbralisib
Clinical Study IdentifierNCT02793583
SponsorTG Therapeutics, Inc.
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion Criteria

Any major surgery, chemotherapy or immunotherapy within the last 21 days
Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
Prior therapy with a PI3K delta inhibitor
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