Overview

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:
Active, not recruiting
Trial end date:
2025-07-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
TG Therapeutics, Inc.
Treatments:
Bendamustine Hydrochloride
Criteria
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