Improving Outcomes in Chronic Lymphocytic Leukemia Trials Through the Integral Role of BICR in Imaging Assessments
Chronic lymphocytic leukemia (CLL) is the most prevalent form of leukemia in adults, typically affecting those aged 65 years and older. While radiologic imaging is not considered as critical for initial diagnosis or during staging, it plays a crucial role in clinical research. CT and/or MRI are vital for evaluating therapeutic responses, with The International Workshop on Chronic Lymphocytic Leukemia (iwCLL) assessment criteria widely used in clinical trials. The iwCLL criteria incorporates tumor measurements, clinical data, and biomarkers to provide a comprehensive evaluation of a patient’s treatment response.
CLL results from the overproduction of lymphocytes, mainly impacting the bone marrow, lymph nodes, and blood. Different subtypes of CLL are categorized based on the specific type of affected lymphocyte type and its growth rate. The most common variant, B-cell chronic lymphocytic leukemia, accounts for approximately 95% of cases. The heterogeneous nature of CLL necessitates precise imaging assessments to effectively monitor disease progression and treatment efficacy, especially as novel therapies emerge.
The iwCLL criteria provides a comprehensive framework for evaluating patient responses to treatment by incorporating parameters such as lymph node size, liver and spleen dimensions, and various blood counts. At Imaging Endpoints, while working on CLL clinical trials, we ensure that we focus not only on imaging but also on clinical data per iwCLL criteria. However, integrating clinical dossiers into clinical trial reads presents challenges, particularly in interpreting blood counts with subtle imaging changes that can complicate assessments. Even experienced reviewers require regular training and monitoring for consistency when evaluating such cases, which could otherwise lead to variability. Additionally, selecting specialized reviewers with expertise in CLL is an emphasis that’s critical for the BICR process. Standardized imaging protocols, clear and optimized response criteria, and regular monitoring of central reads are essential to enhance the assessment reliability and improve patient outcomes in CLL clinical trials.
Dr. Manish Sharma, MD, remains optimistic about technological advancements, stating that “Optimizing imaging methodologies and utilizing AI/LLM (Large Language Models) for clinical dossiers in evolving CLL clinical trials will enhance assessments, improve patient outcomes, and ensure therapy advancements.”
Imaging Endpoints is committed to supporting clinical trials, identifying effective therapies, and providing an improved quality of life for CLL patients. As a global leader in designing the imaging requirements for clinical trial protocols in Chronic Lymphocytic Leukemia, IE has a perfect inspection record and a remarkable 95% marketing authorization success rate across all registration trials. For more information,
