A Study Assessing Minimal Residual Disease to Minimize Side Effects in People with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Were Treated with Venetoclax

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Full Title

Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease by Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL Patients

Purpose

Minimal residual disease (MRD)-negative status means doctors are not detecting cancer cells in the body and patients don’t have any signs or symptoms of cancer. In this study, researchers want to know if people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (CLL) who have received venetoclax and are MRD-negative can safely stop venetoclax treatment for 12 months or more.

The researchers think that stopping treatment with venetoclax in MRD-negative CLL or SLL patients could help prevent the serious side effects that can occur during long-term treatment with this drug. The U.S. Food and Drug Administration has approved MRD testing for use in the treatment of other blood cancers (such as multiple myeloma); its use in this study is considered investigational.

Eligibility

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

  • Patients in this study must be MRD-negative after at least six months of treatment with venetoclax given alone or with another drug.
  • 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

19-395

Phase

II

Investigator

Co-Investigators