12:30 PM – 1:00 PM — Registration and Buffet Lunch
1:00 PM – 3:00 PM — Symposium

MODULE 1: Biomarker Assessment for Patients with Chronic Lymphocytic Leukemia (CLL) — Dr Davids

Sample Consensus-Building/Investigator Survey Questions

• What type of biomarker assessment do you typically order before initiating therapy for a patient with newly diagnosed CLL?
• A 59-year-old man experiencing intermittent night sweats presents with asymptomatic leukocytosis and a white blood cell count that has been increasing steadily for a year (currently 48,000 cells/µL). A diagnostic panel reveals IGHV-mutant CLL but no abnormalities on FISH. The patient’s HgB has dropped from 14 to 11 and his platelet count is 105,000. Would you offer this patient active therapy at this point? What if he were age 75?
• Do you believe it is possible to “cure” patients with normal cytogenetics and IGHV-mutant disease with standard chemoimmunotherapy (eg, FCR)? Can you describe a scenario in which you would recommend something other than chemoimmunotherapy as first-line treatment for a younger patient with IGHV-mutant disease and no adverse risk factors?
• Are patients with only a small percentage of cells positive for del(17p) considered to have “high-risk” disease? If not, what is the specific threshold that you use at your institution to risk stratify these individuals?
• Do you routinely assess minimal residual disease (MRD) status after induction therapy outside of a protocol setting? If so, which assay do you use?
• Do you believe it is essential to repeat FISH testing for individuals who present with relapsed/refractory (R/R) disease? If so, which biomarkers do you routinely check at relapse?

Faculty Presentation/Panel Discussion Topics

• Identification and potential utility of existing and emerging biomarkers (del[17p], del[11q], IGHV mutations, TP53 mutations, complex karyotype, et cetera) to inform patient risk assessment and therapeutic decision-making
• Clinical significance of MRD status on long-term outcomes for patients with CLL; current role, if any, in general oncology practice outside of a trial setting
• Optimal surveillance for patients with newly diagnosed CLL who elect observation over active therapy
• Rationale for guideline-endorsed recommendation for repeat biomarker assessment in patients with progressive CLL

MODULE 2: Biological and Clinical Considerations in the Treatment of Newly Diagnosed CLL — Prof Gribben

Sample Consensus-Building/Investigator Survey Questions

• What is your usual preferred initial regimen for an otherwise healthy 65-year-old patient with IGHV-mutated CLL and normal-risk cytogenetics who requires treatment? What if the patient has nonmutated disease?
• What is your usual preferred initial regimen for an otherwise healthy 80-year-old patient with IGHV-mutated CLL and normal-risk cytogenetics who requires treatment? What if the patient has nonmutated disease?
• What is your usual preferred initial regimen for an otherwise healthy 65-year-old patient with CLL and del(17p) requiring treatment? What if the patient has a history of atrial fibrillation and is receiving anticoagulation?
• What is your usual preferred initial regimen for an otherwise healthy 80-year-old patient with CLL and del(17p) requiring treatment?
• A 65-year-old, otherwise healthy patient with asymptomatic CLL meets the criteria for observation but has del(17p). Would you administer treatment?
• A patient with newly diagnosed del(17p) CLL receives standard-dose ibrutinib and experiences a rapid and durable response to therapy but also significant gastrointestinal toxicity that cannot be controlled with antidiarrheals alone. How would you approach this situation?

Faculty Presentation/Panel Discussion Topics

• Long-term efficacy outcomes observed in published clinical trials of commonly employed induction regimens (eg, FCR, BR, ibrutinib, obinutuzumab/chemotherapy)
• Monitoring for and management of toxicities associated with the use of chemoimmunotherapy or ibrutinib in patients with newly diagnosed CLL

MODULE 3: Contemporary Management of R/R CLL — Dr Friedberg

Sample Consensus-Building/Investigator Survey Questions

• Reimbursement and regulatory issues aside, what second-line therapy would you recommend for an otherwise healthy 80-year-old patient with average-risk CLL who responded to ibrutinib and then experienced disease progression 2 years later? What if the patient were age 65? What if the patient had del(17p) disease?
• Reimbursement and regulatory issues aside, what second-line therapy would you recommend for an otherwise healthy 65-year-old patient with CLL and normal-risk cytogenetics who responded to BR and then experienced disease progression 3 years later? What if the patient received FCR? What if the patient relapsed 18 months after induction therapy?
• Based on current clinical trial data and your personal experience, how would you compare the global toxicity of acalabrutinib to that of ibrutinib? How would you compare the global efficacy of acalabrutinib to that of ibrutinib?
• What is known about the relative risk of atrial fibrillation and bleeding with acalabrutinib versus ibrutinib in CLL?
• For a patient receiving ibrutinib for whom you have determined therapeutic discontinuation is warranted because of uncontrollable atrial fibrillation, would you consider switching to acalabrutinib?

Faculty Presentation/Panel Discussion Topics

• Key efficacy and safety findings from the Phase III MURANO trial comparing venetoclax/rituximab to bendamustine/rituximab for R/R CLL; recent FDA approval of venetoclax for patients without del(17p)
• Mechanistic similarities and differences between acalabrutinib and ibrutinib; potential impact on clinical outcomes
• Available efficacy and safety data with acalabrutinib in CLL; ongoing Phase III Elevate CLL R/R study of acalabrutinib versus ibrutinib for patients with R/R disease
• Individualizing the selection and sequencing of therapies in the R/R setting based on induction regimen received, disease-free interval and other clinical and biologic factors

MODULE 4: Novel Agents and Strategies Under Investigation in CLL — Dr Kipps

Sample Consensus-Building/Investigator Survey Questions

• In the era of novel therapies, do you believe clinical trial participation still represents a preferred therapeutic option for patients with CLL?
• Which novel agents or strategies, if any, do you believe are particularly promising for patients with either newly diagnosed or relapsed CLL?
• What is the incidence of Richter’s transformation in patients with CLL? When does transformation typically occur, and how do you generally manage these cases? Would you consider the use of an anti-PD-1/PD-L1 antibody outside of a trial for a patient with CLL and Richter’s transformation?

Faculty Presentation/Panel Discussion Topics

• Biologic rationale for, early activity data with and ongoing evaluation of novel combination approaches in patients with untreated and R/R CLL
• Mechanism of action, tolerability and ongoing investigation of other novel agents in CLL