A Phase II Study of Ublituximab and Umbralisib in Combination with Ibrutinib or Venetoclax to Treat Chronic Lymphocytic Leukemia

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Full Title

A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib (TGR-1202) in Subjects with Chronic Lymphocytic Leukemia (CLL) Currently Treated with Ibrutinib or Venetoclax Alone or in Combination with an Anti-CD20 Antibody

Purpose

The purpose of this study is to assess the safety and effectiveness of giving ublituximab and umbralisib with either ibrutinib or venetoclax in patients with chronic lymphocytic leukemia (CLL) who are responding to treatment but still have some leukemia cells in the body (“minimal residual disease”). All patients will receive ublituximab and umbralisib in addition to the ibrutinib or venetoclax they are already receiving.

Umbralisib works by blocking a protein in the blood called PI3K. In CLL, this protein triggers cancer cells to develop and helps them survive. Blocking PI3K may slow the spread of CLL. Ublituximab is an antibody that attaches to a protein (CD20) on the surface of CLL cells and some healthy blood cells. Once attached to CD20, ublituximab helps the immune system destroy CLL cells and kills the cancer cells directly.

Ibrutinib and venetoclax are already used to treat CLL. Their use in combination with ublituximab and umbralisib is investigational. Researchers think the combination of ublituximab and umbralisib with these targeted therapies can help clear leukemia cells from the body faster than standard treatments. Umbralisib, ibrutinib, and venetoclax are taken orally (by mouth) and ublituximab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have CLL and have been receiving ibrutinib or venetoclax for 6 months or more.
  • Patients must have minimal residual disease.
  • At least 3 weeks must have passed since finishing any other cancer therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 212-639-8596.

Protocol

19-225

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators