A pharmacist-led clinic was able to safely and effectively manage venetoclax ramp-up for patients with chronic lymphocytic leukemia (CLL) at low to moderate risk for tumor lysis syndrome (TLS), according to a new retrospective study published in the Journal of Oncology Pharmacy Practice.1
The clinic achieved a 94.3% success rate in getting patients to the target 400 mg dose, while keeping rates of serious TLS—a possible adverse effect of venetoclax—remarkably low. None of the 88 patients in the study developed clinical TLS while 2 experienced laboratory TLS.
Pharmacists adjusted therapy to prevent TLS in 12.5% of all visits. | Image credit: Chinnapong – stock.adobe.com
TLS is a potentially life-threatening complication associated with rapid cancer cell death during treatment, and venetoclax initiation requires careful monitoring through a 5-week dose ramp-up.2 This typically resource-intensive process involves frequent lab assessments and clinical visits, but this pharmacist-led model could provide an alternative that maintains safety while potentially reducing the burden on hematologists, according to the study authors.1
“Ongoing visits throughout ramp-up are necessary as evidenced by the frequent modifications to therapy made for the purpose of TLS prevention,” the authors said. “By practicing to full scope, the clinic pharmacists managed TLS and IBA's appropriately, mitigating adverse patient outcomes and ultimately providing a valuable service to CLL patients and the larger hematology-oncology interdisciplinary team.”
To come to this finding, researchers evaluated records of 88 patients with CLL who visited the pharmacist-led clinic between October 2020 and January 2024. With a median age of 70, most of them were at low or moderate risk of TLS. Pharmacists in the clinic followed a structured institutional protocol, providing patient education, reviewing lab data, and independently adjusting medications and TLS prophylaxis during the ramp-up phase. About 30 patients were seen each year on average with a team of 3 rotating clinical pharmacists.
A total of 907 clinic visits were analyzed, with education provided at all of them. Pharmacists made changes to therapy to prevent TLS in 12.5% of all visits and intervened during 75% of visits where laboratory TLS occurred. They also managed other adverse events and drug interactions independently, referring patients to hematologists for these events only when necessary.
Beyond safety, the study also highlighted the importance of ongoing monitoring. Most active changes to TLS prophylaxis or treatment occurred early in the ramp-up, particularly at venetoclax doses of 100 mg or less, underscoring the need for intensive early follow-up. The authors suggested future research could explore whether less frequent monitoring is appropriate after patients surpass that threshold, especially in low-risk populations.
The study also highlighted pharmacists’ expertise in managing venetoclax-related drug interactions, which were seen in nearly 16% of patients. All interactions were managed independently by pharmacists, often through adjustments to concurrent medications or venetoclax dosing.
According to the authors, their study’s findings are consistent with prior real-world data and clinical trials, though it’s important to note its single-center design with a relatively small sample size and that these results may not be applicable to patients at a higher risk of TLS until further research.
“However, despite this, it did capture the majority of CLL patients who started on venetoclax during our study period reflecting real life practice,” the authors noted. "Given the retrospective nature of our study, our data was subject to chart documentation, which may not have captured all activities and outcomes.”
References
de Boer A, McCaw C, Ackman M, Leslie T, Peters A, Koshman S. Evaluating the impact of a pharmacist-led venetoclax ramp-up clinic for chronic lymphocytic leukemia patients: a retrospective chart review. J Oncol Pharm Pract. Published online March 21, 2025. doi:10.1177/10781552251324522
Anderson MA, Walewska R, Hackett F, et al. Venetoclax initiation in chronic lymphocytic leukemia: international insights and innovative approaches for optimal patient care. Cancers (Basel). 2024;16(5):980. doi:10.3390/cancers16050980