A Phase 2 Study of Venetoclax, Obinutuzumab, and Acalabrutinib to Treat Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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Full Title

A phase 2 study of MRD adapted therapy with venetoclax-obinutuzumab in patients with relapsed or refractory CLL, with addition of acalabrutinib in patients with persistent MRD

Purpose

The purpose of this study is to assess the safety of new drug combinations and see how well they work. The people in this study have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that keeps growing after treatment. The three drugs are venetoclax, obinutuzumab, and acalabrutinib.

If you join this study, you will first get venetoclax and obinutuzumab. If the treatment works well, you will keep taking venetoclax alone. If cancer cells can still be found after venetoclax and obinutuzumab, you will get venetoclax with acalabrutinib.

Venetoclax works against cancer by blocking a protein that helps cancer cells survive and resist the effects of cancer treatments. Obinutuzumab helps the immune system recognize and attack cancer cells. Acalabrutinib blocks a protein that can help cancer cells multiply and survive. Venetoclax and acalabrutinib are both taken orally (by mouth), and obinutuzumab is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have CLL or SLL that keeps growing or came back after treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please contact Dr. Andrew Zelenetz’s office at 646-608-3728.

Protocol

22-359

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04560322