Phase 3 trial for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with BTK and BCL-2 inhibitors

Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow produces large numbers of abnormal B lymphocytes and releases them into the blood. Lymphocytes are a subgroup of white blood cells and part of the immune system. When the abnormal cells are found primarily in the lymph nodes and spleen, the condition is referred to as small-cell lymphocytic lymphoma (SLL). Both conditions are very similar and are often considered together. CLL is a type of non-Hodgkin lymphoma; it usually occurs in older adults and often progresses slowly over many years. Treatment is only necessary if certain risk factors or symptoms are present. Immunochemotherapy is typically used in such cases, often involving BTK or BCL-2 inhibitors, each of which specifically blocks a growth-promoting protein in the cancer cells.

If the disease returns (recurrence) or does not respond to therapy (refractory), the treatment must be adjusted. This is where the CaDAnCe-302 study comes in. It is investigating BGB-16673, a novel BTK inhibitor that has so far only been available in clinical trials. The goal of this Phase 3 trial is to determine whether BGB-16673 is more effective than one of three established treatment combinations.

Half of the study participants will receive the study drug BGB-16673, while the other half will receive standard therapy selected by the treating physicians: either idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or re-treatment with venetoclax plus rituximab. Idelalisib is a targeted agent that inhibits a specific enzyme (PI3Kδ), thereby limiting cancer cell growth. Rituximab is an antibody that makes cancer cells visible to the immune system. Bendamustine is a chemotherapy drug that damages the genetic material of cancer cells, and venetoclax is a BCL-2 inhibitor that specifically blocks a protein in cancer cells that promotes their survival. Assignment to the two treatment groups is done at random (randomized); all participants are aware of their assignment (open-label).

Eligible participants include women and men aged 18 and older with confirmed CLL or SLL who have already been treated with BTK and BCL-2 inhibitors and now require further therapy. A prerequisite is good overall health. Study participants will be monitored for approximately 36 months.