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ICML 2025 | The Safe Accelerated Venetoclax Escalation (SAVE) study: accelerated dose ramp-up in CLL
Jennifer Crombie, MD, Dana-Farber Cancer Institute, Boston, MA, presents results from the Phase Ib Safe Accelerated Venetoclax Escalation (SAVE) study (NCT04843904), exploring venetoclax with an accelerated dose ramp-up in patients with chronic lymphocytic leukemia (CLL). The study found the accelerated dose escalation to be safe, and Dr Crombie suggests that this strategy can be a helpful approach for many patients and physicians. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
Yeah, so at this meeting I’m presenting the results of our phase 1b study called SAVE, which stands for Safe Accelerated Venetoclax Escalation for patients with chronic lymphocytic leukemia. We know that venetoclax is a very active therapy for patients with CLL and it’s approved in both the frontline and relapsed/refractory setting. However, it is difficult to use for many patients because of the cumbersome five-week dose escalation ramp-up that’s required to mitigate the risk of tumor lysis syndrome, which is a known side effect of venetoclax...
Yeah, so at this meeting I’m presenting the results of our phase 1b study called SAVE, which stands for Safe Accelerated Venetoclax Escalation for patients with chronic lymphocytic leukemia. We know that venetoclax is a very active therapy for patients with CLL and it’s approved in both the frontline and relapsed/refractory setting. However, it is difficult to use for many patients because of the cumbersome five-week dose escalation ramp-up that’s required to mitigate the risk of tumor lysis syndrome, which is a known side effect of venetoclax. So in this investigator-sponsored study, we aimed to evaluate whether we could safely escalate patients with CLL starting venetoclax on a more accelerated timeline with daily dose increases. So this was done in the inpatient setting and patients received an accelerated and increased dose of venetoclax each day with close monitoring of tumor lysis syndrome labs. We also started with patients who were at low risk for tumor lysis syndrome, and if it was seen to be safe in that cohort, we expanded the study to include patients with medium to high-risk tumor lysis syndrome. So we had 40 patients enroll in this study, 25 from cohort A, which was the low-risk cohort, and the remainder from the medium to high-risk cohort, and we saw that this method was safe. We had only one patient who was at high risk for tumor lysis syndrome develop laboratory TLS, and no patients experienced clinical tumor lysis syndrome. That patient who did have laboratory tumor lysis syndrome received therapy and improved within two days with an extension of their inpatient stay only for a brief period of time. Of note, CD20 antibody use was at the discretion of the treating provider, and the majority of the patients in our study did receive a CD20 antibody prior to venetoclax treatment, which may have helped debulk many of these patients. So overall, we think this is a strategy that can be helpful for many patients and physicians and something to be considered if the appropriate monitoring is in place.
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