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


Lymphoma -> Mantle Cell Lymphoma (MCL) {Who have previously received a BTK inhibitor}, marginal zone lymphoma (MZL), follicular lymphoma (FL) small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL)


Lymphomas are cancers of white blood cells that can be divided into indolent (slow growing) and aggressive (fast growing), though share common features that can be targeted by anti-cancer drugs.

This trial is for patients who have non-Hodgkin lymphoma which has returned after treatment. All patients will receive umbralisib, a tablet that targets an important pathway in the lymphoma called phosphatidylinositol-3-kinase delta (PI3K), which stops cancer cells from growing. Depending on the type of lymphoma, the some patients will also receive a lymphoma targeting antibody called ublituximab (intravenous) and/or a chemotherapy drug called bendamustine (intravenous).

The aim of the trial is to see whether the combinations of umbralisib, ublituximab, and bendamustine are effective in treating lymphoma.


Include, but not limited to, the following:

Inclusion Criteria:
1. Diagnosis of Non-Hodgkin's Lymphoma (including Diffuse Large B-cell Lymphoma, Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma)
2. Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

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

Contact person:

Elizabeth Smith
Email SmithElizabeth1@ramsayhealth.com.au
Phone 08 9346 6249

Louise Hay
Email Louise.hay@health.wa.gov.au
Phone 08 6386 3207

Principal Investigator:

Dr Chan Cheah

08 9389 1030


TG Therapeutics



Protocol Number:


Trial Registration Number:


Clinical Trials.gov

ANZ Clinical Trial Registry