Michallet, Mauricette, Dreger, Peter, Sobh, Mohamad, Koster, Linda, Hoek, Jennifer, Boumendil, Ariane, Scheid, Christof, Fox, Christopher P., Wulf, Gerald, Krüger, William, van Gelder, Michel, Corradini, Paolo, Russo, Domenico, Passweg, Jakob, Schoemans, Hélène, Bethge, Wolfgang, Schaap, Nicolaas, Cornelissen, Jan, Browne, Paul, Durakovic, Nadira, Muller, Lutz, Montoto, Silvia, Kroger, Nicolaus, and Schetelig, Johannes
The purpose of our study is to provide information on safety and efficacy of ibrutinib as salvage treatment after allo-HSCT for CLL. A total of 56 patients were included, 36 (64%) males; median age at transplantation was 48 years (range: 35–64) and the median number of treatment lines prior to transplantation was 3 (1–10). The median time between allo-HSCT and Ibrutinib was 30 months (range: 1–140). Overall, 40 (71%) patients responded to Ibrutinib; 23 (41%) PR, and 17 (30%) CR. At time of ibrutinib initiation, ten patients had active chronic GVHD that resolved under Ibrutinib, whilst a single patient developed limited de novo chronic GVHD on Ibrutinib. Fourteen patients discontinued ibrutinib, four because of toxicity and ten because of disease progression. Overall, 14 patients progressed (median PFS = 24 months) among them 10 died. Two-year OS and PFS probabilities were 72% (95% CI: 52–84) and 50% (95% CI: 32–66), respectively. Patients with late relapse after allo-HSCT (≥24 months) had a better PFS after ibrutinib. Our study shows that ibrutinib can be safely administered for CLL relapse after allo-HSCT, with comparable efficacy to non-transplanted patients with high-risk disease.