A Phase II Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia

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Full Title

Phase 2 Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

Purpose

The purpose of this study is to assess the safety and effectiveness of combination therapy with zanubrutinib, obinutuzumab, and venetoclax in patients newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).

Obinutuzumab targets a protein called CD20, which is found on the surface of B cells (the white blood cells that are affected by CLL and SLL). Obinutuzumab destroys B-cells by direct killing as well as making them more visible to the immune system, which then attacks and destroys B-cells.

Venetoclax blocks a protein called Bcl-2 in cancer cells. Bcl-2 helps cancer cells survive and resist the effects of cancer treatments. By blocking Bcl-2, venetoclax may kill cancer cells and/or make them more vulnerable to the effects of other cancer treatments. Zanubrutinib blocks a protein in B-cells called Bruton tyrosine kinase (BTK). BTK helps CLL/SLL cells live and grow. By blocking BTK, zanubrutinib may slow or stop the activity of CLL/SLL cells.

Obinutuzumab is given intravenously (by vein), while venetoclax and zanubrutinib are taken orally (by mouth).

Eligibility

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

  • Patients must be newly diagnosed with CLL or SLL that has not yet been treated with targeted therapies or chemotherapy.
  • 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. Andrew Zelenetz at 212-639-2656.

Protocol

18-427

Phase

II

Disease Status

Newly Diagnosed

Investigator

Zelenetz, Andrew, MD, PhD

Co-Investigators