Phase II Trial Focuses on Short-Course Fludarabine With Continuous Ibrutinib in CLL
Posted: Wednesday, November 4, 2020
Ibrutinib in combination with a short course of fludarabine led to a higher complete response than traditional therapeutics in patients with treatment-naive chronic lymphocytic leukemia (CLL), based on the findings of a phase II trial. Inhye E. Ahn, MD, of the National Institutes of Health, and colleagues conducted this study during which a short course of fludarabine was added to continuous dosing of ibrutinib. They found that not only were T cells elevated before treatment and normalized after treatment, but two protumor T-cell populations significantly decreased during therapy. Their results were published in the American Journal of Hematology.
In total, 29 people with CLL were enrolled in the study. The overall response rate after 6 months was 93.1%, and all evaluable patients were progression-free. At the median follow-up of 29 months, 82.8% of patients (n = 24) remained progression-free and on the study. The complete response rates were 20.7% at 6 months, 28% at 12 months, and 44.4% at 24 months.
The majority (83.0%) of treatment-related adverse events were grade 1 or 2; the most common adverse events were bruising (65.5%), diarrhea (44.8%), myalgia (41.4%), and arthralgia (37.9%). The most commonly observed grade ≥ 3 cytopenias were associated with the addition of fludarabine and resolved with continuously administered ibrutinib and supportive care. Two patients discontinued study treatment due to hepatotoxicity, although one did not receive any fludarabine, and the second patient received one cycle and achieved a partial response.
Based on their results, the researchers noted that “a longer follow-up is warranted to determine the durability of response and the role of a complete response in predicting outcomes.”
Disclosure: For full disclosures of the study authors, visit onlinelibrary.wiley.com.
