A prospective, open-label, Phase IIb/III study is underway to evaluate the risk of tumor lysis syndrome (TLS) and optimize dosing strategies for venetoclax in combination with either obinutuzumab or acalabrutinib in adult patients with chronic lymphocytic leukemia (CLL). The trial, known as M24-287, is enrolling approximately 120 participants across roughly 80 sites globally.
Chronic lymphocytic leukemia is the most prevalent type of leukemia, characterized by the proliferation of cancerous blood cells. This study seeks to improve the safety profile of venetoclax, a BCL-2 inhibitor, when used in conjunction with other targeted therapies. The primary focus is on assessing adverse events, particularly TLS, and monitoring changes in disease activity.
Study Design and Treatment Arms
Participants are being assigned to one of four treatment arms. Arm A involves oral venetoclax combined with intravenously infused obinutuzumab, incorporating a 5-week venetoclax ramp-up period. Arm B combines oral venetoclax with oral acalabrutinib, also with a 5-week venetoclax ramp-up. Arms C and D both administer oral venetoclax in combination with oral acalabrutinib but utilize differing venetoclax ramp-up periods.
The total study duration is projected to be approximately 28 months, during which participants will be required to attend regular visits at a hospital or clinic. These visits will involve medical assessments, blood tests, monitoring for side effects, and completion of questionnaires to evaluate the treatment's impact.
Monitoring and Assessments
The trial's endpoints include the incidence of TLS, as well as changes in CLL disease burden and overall safety. Researchers will be meticulously tracking adverse events and assessing the efficacy of the different venetoclax combination regimens. The data collected will provide valuable insights into optimizing treatment strategies for CLL patients receiving venetoclax-based therapies.
