Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Sponsor: SWOG

https://clinicaltrials.gov/ct2/show/NCT04269902

• Must have been diagnosed with CLL or SLL within the last 12 months.
• HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
• A history of malignancy is allowed providing the cancer has not required active treatment within the last 2 years (hormonal therapy is permissible). Some exceptions are permissible including basal cell, squamous cell skin, or non-melanomatous skin cancer, and others
• Must not have received any prior CLL- or SLL-directed therapy
• Must not have cirrhosis, known bleeding disorders, history of stroke or intracranial hemorrhage (within 6 months), any currently active cardiovascular disease, a history of myocardial infarction, unstable angina, or acute coronary syndrome (within 6 months