Dr. Shah on Challenges With Developing MCL Clinical Trials

Bijal D. Shah, MD, associate member, Department of Malignant Hematology, Moffitt Cancer Center, assistant professor of oncology, University of South Florida, discusses challenges with conducting clinical trials in mantle cell lymphoma (MCL).

Mainly, accruing patients for clinical trials is the biggest obstacle that researchers face. In general, MCL is a disease that tends to present in older patients with a median age of 68 years. These patients tend to want to receive their treatment locally. Furthermore, they are less likely to switch from a community oncology center to a large academic center that is farther away unless they have advanced disease, Shah notes. Patients also develop close relationships with their community oncologists, which might make them hesitant to receive care elsewhere.

Moreover, MCL clinical trials tend to have a strict inclusion criteria. As such, it becomes hard for researchers to focus on individual subsets of patients like those with p53 mutations or those with highly proliferative disease. Shah adds that academic centers such as Moffitt Cancer Center, The University of Texas MD Anderson Cancer Center, and John Theurer Cancer Center have large groups of patients with MCL, which makes it easier to develop trials. He adds that although these are the fears that are often communicated, he cannot confirm that they are justified.