A Phase III Study Assessing Early versus Delayed Treatment with Venetoclax and Obinutuzumab for Newly Diagnosed Patients with High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma without Symptoms

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Full Title

Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus DeLayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study (CIRB)

Purpose

In this study, researchers are comparing early treatment with venetoclax and obinutuzumab versus delayed treatment with these two medications in patients with newly diagnosed high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are not experiencing symptoms. Starting treatment with these drugs early (before patients have symptoms) may be more effective than delaying treatment until symptoms emerge.

Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Venetoclax is taken orally (by mouth) and obinutuzumab is given intravenously (by vein). Patients will be randomly assigned to receive treatment either before or after they have symptoms.

Eligibility

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

  • Patients must have previously untreated high-risk CLL or SLL that is not yet causing symptoms.
  • 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. Lindsey Roeker at 646-608-4115.

Protocol

21-117

Phase

III

Investigator

Co-Investigators