The trial focuses on patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia that have changes in the TP53 gene, such as a missing piece of chromosome 17 detected by FISH or a mutation. The treatment combines an intravenous infusion of obinutuzumab, an oral tablet of nemtabrutinib, and an oral tablet of venetoclax.
The aim is to see how well this combination works in eliminating disease and keeping it from coming back. Response will be measured by checking the amount of cancer left in the bone marrow using a laboratory technique called flow cytometry to find minimal residual disease at a very low level.
Participants will receive the infusion and tablets over several months, completing about 15 cycles of the oral drug, 12 cycles of the second oral drug, and six infusions of the first drug. After treatment, doctors will follow the patients to record how long they stay free of disease, known as progression-free survival, overall length of life, called overall survival, and any side effects, which are graded using the standard CTCAE criteria and the disease‑specific iwCLL guidelines.
France 
