A Phase II Study of Venetoclax and Obinutuzumab as Initial Therapy for Chronic Lymphocytic Leukemia

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Full Title

A Phase II Venetoclax-Based Therapy for the Treatment of Fit Patients with Chronic Lymphocytic Leukemia (CLL) in the Front-Line Setting

Purpose

The combination of venetoclax and obinutuzumab can delay or stop the growth of chronic lymphocytic leukemia (CLL) because each drug attacks different proteins found in CLL. Venetoclax blocks a protein called Bcl-2. Obinutuzumab targets a protein called CD20, which is found on the surface of B cells (the white blood cells that are affected by CLL). These drugs are often given in combination for up to one year. However, venetoclax is not usually given beyond one year.

In this study, researchers are evaluating the combination of venetoclax and obinutuzumab in patients with CLL who have not yet been treated. They will look at how helpful this combination is when given during two different lengths of time: venetoclax plus obinutuzumab for 12 months, and then, if there is still evidence of disease found in the blood, venetoclax alone for an additional year. Venetoclax is taken orally (by mouth) and obinutuzumab 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.
  • Patients may not have previously received treatment for CLL.
  • 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 646-608-3748.

Protocol

20-044

Phase

II

Disease Status

Newly Diagnosed

Investigator