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 -> 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:

• Patients must be aged above 18 years of age
• A diagnosis of B-cell lymphoma which has continued to grow (refractory) or returned (relapsed) after previous treatment
• No previous use of PI3k inhibitors (e.g. idelalisib)
• No other active cancers (other than some cancers cured with minor operations like skin cancer)
• No other major health problems

Contact person:

Astrid Bauwens

Email BauwensA@ramsayhealth.com.au

Phone 08 9346 6637

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