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

a study on Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

Official Title

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

Details

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).

Keywords

Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma DLBCL FL MZL MCL SLL Non-Hodgkin's Lymphoma Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large B-Cell, Diffuse Bendamustine Hydrochloride Ublituximab Umbralisib Bendamustine Umbralisib + Ublituximab Umbralisib + Ublituximab + Bendamustine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • TG Therapeutics Investigational Trial Site accepting new patients
    Los Angeles California 90095 United States
  • TG Therapeutics Investigational Trial Site completed
    San Diego California 92108 United States
  • TG Therapeutics Investigational Trial Site completed
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TG Therapeutics, Inc.
ID
NCT02793583
Phase
Phase 2/3
Study Type
Interventional
Last Updated