Paradigm Shift in the Management of Patients with Previously Untreated Chronic Lymphocytic Leukemia through NCI-sponsored Clinical Trials - PROJECT SUMMARY Dr. Parikh is a consultant in the Division of Hematology, Department of Medicine at Mayo Clinic in Rochester, MN, and holds the rank of Associate Professor of Medicine with the Mayo Clinic Alix School of Medicine. Dr. Parikh is also a member of the CLL Disease Team and the Lymphoid Malignancies Disease Group of the Mayo Clinic Comprehensive Cancer Center. Since joining on staff at Mayo Clinic, his clinical and research efforts have focused on chronic lymphocytic leukemia (CLL). Dr. Parikh’s overall goal is to improve the care of patients with CLL through the development of novel clinical trials in collaboration with the National Clinical Trials Network (NCTN). To further his objectives, Dr. Parikh proposes with this R50 application to: 1) complete the ECOG-ACRIN trial “EA9161: A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)”, and the Alliance for Clinical Trials in Oncology clinical trial “A041702 A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)”; and participate in the final outcome analysis, correlative biomarker analysis, and drafting of abstracts and manuscripts; 2) develop the study protocol and serve as the National PI for the next ECOG-ACRIN-led frontline CLL protocol titled “EA9231: Measurable Residual Disease Guided Frontline Therapy in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Patients <70 Years”. In addition to writing the study protocol and activating the study, Dr. Parikh will also be responsible for completing the final analysis, and publish relevant abstracts and manuscripts that will result from this work; and 3) serve as the Mayo Clinic PI for the next Alliance in Clinical Trials in Oncology clinical trial that will test the utility of measurable residual disease in older patients (>65 years) with previously untreated CLL. Additionally, in his role as the Chair of the CLL Disease Team and Vice Chair of the Lymphoid Malignancies Disease Group of the Mayo Clinic Comprehensive Cancer Center, Dr. Parikh oversees the strategic plans for all clinical trials in CLL across the Mayo Enterprise, including NCTN-sponsored trials. Dr. Parikh also participates and actively collaborates on several correlative studies that are being conducted on samples collected from CLL patients enrolled on ECOG-ACRIN trials across the country. Dr. Parikh views the opportunity to submit this application for the NCI Research Specialist (Clinician Scientist) R50 award as a significant and critical opportunity to continue his career goal of developing, implementing, and completing the most cutting-edge and state-of-the-art clinical trials in CLL conducted by the NCTN.
