Clinical trials are incredibly important for both patients and scientists. Patients receive quality care and access to some of the newest therapies available. Scientists learn more about the safety and effectiveness of new treatments and about the biology of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL / SLL) so that they can help more patients in the future. At the annual meeting of the European Hematology Association (EHA) 2021, CLL Society’s own Dr. Brian Koffman spoke with Dr. Jennifer Woyach, a professor of medicine and hematologist at the James Cancer Center of the Ohio State University, about two ongoing clinical trials that are currently recruiting patients with CLL.
Study #1: Testing the Addition of a New Anti-Cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients with Chronic Lymphocytic Leukemia
Main research question: Does the addition of venetoclax to the usual treatment prevent chronic lymphocytic leukemia from returning?
Study Type: Phase III clinical trial
Patients: Age 70+ with previously untreated CLL
Intervention: Patients will be randomized to receive either ibrutinib + obinutuzumab or ibrutinib + obinutuzumab + venetoclax for 1 year and then will be evaluated for MRD status for MRD-guided discontinuation of treatment
Investigator: Dr. Jennifer Woyach, Alliance for Clinical Trials in Oncology
More information: https://clinicaltrials.gov/ct2/show/NCT03737981
Study #2: Testing the Effects of Early Treatment with Venetoclax and Obinutuzumab Versus Delayed Treatment with Venetoclax and Obinutuzumab for Newly Diagnosed Patients with High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Do Not Have Symptoms, the EVOLVE CLL / SLL Study
Main Research Question: Does starting treatment earlier (before symptoms start) prolong survival?
Study type: Phase III clinical trial
Patients: Newly diagnosed with CLL within the last year, and who have a higher-risk disease (ie, del17p deletion, TP53 mutation, IGHV unmutated)
Intervention: Patients will be randomized to receive venetoclax + obinutuzumab starting either around the time of diagnosis or when symptoms develop (which is when treatment would normally start)
Investigator: Dr. Deborah Stephens, Southwestern Oncology Group
More information: https://clinicaltrials.gov/ct2/show/NCT04269902
Please enjoy this brief interview with Dr. Woyach from the virtual EHA meeting which was held June 2021.
Take care of yourself first.
Ann Liu, PhD