BTK inhibitors are an effective therapy for previously untreated patients with CLL but require indefinite duration treatment that can result in cumulative toxicities. Novel combinations of agents that provide deep remissions could allow for fixed duration therapy. Acalabrutinib, unlike ibrutinib, does not inhibit anti-CD20 monoclonal antibody dependent cellular phagocytosis, making it a suitable partner drug to rituximab. Using standard dosing (375mg/m2) of rituximab causes loss of target membrane CD20 immune cells and exhaustion of the finite cytotoxic capacity of the innate immune system. Alternatively, using high frequency, low dose (HFLD), subcutaneous rituximab limits loss of CD20 and allows for self-administration at home by patients. The combination of HFLD rituximab 50mg given twice a week for six cycles of 28 days with the addition of acalabrutinib starting in week 2 was evaluated in a phase II study (#NCT03788291 at clinicaltrials.gov) of 38 patients with treatment naive CLL. Patients achieving a complete response with undetectable MRD after 12 or 24 cycles of acalabrutinib could stop therapy. All patient responded, including one with a complete response with undetectable MRD in the peripheral blood and bone marrow at 12 months who stopped therapy. At a median follow-up of 2.3 years two patients with high-risk features have progressed while on acalabrutinib monotherapy. We conclude that HFLD rituximab in combination with acalabrutinib is an effective and tolerable self-administered home combination that provides a platform to build upon future regimens that may more reliably allow for fixed-duration therapy.
188 Background: Quality improvement and patient safety education is an Accreditation Council for Graduate Medical Education (ACGME) common program requirement for hematology/oncology fellowships. Specifically, the ACGME requires trainee participation in interprofessional clinical patient safety activities, such as root cause analyses. These can be challenging to incorporate into busy schedules and are intimidating to some trainees, but simulated RCAs are a novel way to assure trainees gain important patient safety skills. We report on a multicentered experience utilizing a simulated RCA educational module in an attempt to provide fellows with the tools needed to participate in a live RCA and to increase awareness of the need to analyze patient safety events. Methods: The two-hour module included a didactic session explaining the basics of an RCA including common terminology, effective chart review, and personal interviews. The fellows assessed a patient safety event of a missed coagulopathy and created an event flow map and fishbone analysis. They then formed root cause/contributing factor statements and proposed a solution. Seventeen fellows from two institutions completed pre- and post-session surveys regarding the experience. Results: There was a 47% increase in both the percentage of fellows who felt comfortable participating in live RCAs in the future, and in the number of fellows who felt comfortable with using the tools typically utilized in an RCA. 70.59% of respondents felt that as a result of the mock RCA, they were more likely to report a near miss or adverse event. Conclusions: Mock RCAs are a feasible method of incorporating ACGME-required patient safety activities into hematology/oncology fellow education and are effective in increasing their comfort and understanding of important quality improvement skills
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