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
Stopped early · Phase 2/Phase 3
Conditions studied: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma
In brief
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
Key facts
- Study ID
- NCT02793583
- Run by
- TG Therapeutics, Inc.
- People needed
- 710
- Starts
- 2016-05-25
- Expected to finish
- 2022-07-04
- Last updated by the study team
- 2022-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- TG Therapeutics Investigational Trial Site — Huntsville, Alabama, United States
- TG Therapeutics Investigational Trial Site — Chandler, Arizona, United States
- TG Therapeutics Investigational Trial Site — Tucson, Arizona, United States
- TG Therapeutics Investigational Trial Site — Tucson, Arizona, United States
- TG Therapeutics Investigational Trial Site — Los Angeles, California, United States
- TG Therapeutics Investigational Trial Site — Orange, California, United States
- TG Therapeutics Investigational Trial Site — San Diego, California, United States
- TG Therapeutics Investigational Trial Site — San Diego, California, United States
- TG Therapeutics Investigational Trial Site — Whittier, California, United States
- TG Therapeutics Investigational Trial Site — Aurora, Colorado, United States
- TG Therapeutics Investigational Trial Site — Denver, Colorado, United States
- TG Therapeutics Investigational Trial Site — Fort Collins, Colorado, United States
- TG Therapeutics Investigational Trial Site — Bridgeport, Connecticut, United States
- TG Therapeutics Investigational Trial Site — Newark, Delaware, United States
- TG Therapeutics Investigational Trial Site — Washington D.C., District of Columbia, United States
- TG Therapeutics Investigational Trial Site — Boca Raton, Florida, United States
- TG Therapeutics Investigational Trial Site — Fort Myers, Florida, United States
- TG Therapeutics Investigational Trial Site — Gainesville, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — Miami, Florida, United States
- TG Therapeutics Investigational Trial Site — St. Petersburg, Florida, United States
- TG Therapeutics Investigational Trial Site — Tallahassee, Florida, United States
- TG Therapeutics Investigational Trial Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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