UNITY-NHL

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

Disease:

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)

Summary:

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.

Eligibility:

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 6457 3207

Principal Investigator:

Dr Chan Cheah

08 9389 1030

Sponsor:

TG Therapeutics

Phase:

IIb

Protocol Number:

UTX-TGR-205

Trial Registration Number:

NCT02793583

Clinical Trials.gov

ANZ Clinical Trial Registry