Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

a study on Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma Mantle Cell 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 + TGR-1202 with or without Bendamustine and TGR-1202 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 + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

Keywords

Diffuse Large B-Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Bendamustine Hydrochloride Antibodies, Monoclonal TGR-1202 + Ublituximab TGR-1202 TGR-1202 + Ublituximab + Bendamustine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, 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
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

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 accepting new patients
    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