Open-Label Early-Access Programs (EAPs) for Ibrutinib in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia (CLL) or Mantle-Cell Lymphoma (MCL)

Conclusions: This is the first real-world experience with ibrutinib monotherapy for CLL and MCL in Brazil. Overall, treatment was well tolerated with no unexpected toxicities. No atrial fibrillation or bleeding AEs were reported. Of 32 patients with relapsed/refractory CLL, 24 (80%) remained on therapy, 4 (12.5%) discontinued due to AEs, 1 (3.1%) each died or experienced disease progression. Among 13 patients with relapsed/refractory MCL, 5 (38.5%) remained on the therapy, 3 (23.1%) died and 5 (38.5%) experienced disease progression.DisclosuresChiattone: Janssen: Honoraria, Research Funding. Fogliatto: Novartis: Consultancy; Janssen: Honoraria, Research Funding; Roche: Consultancy, Speakers Bureau. Scheinberg: Novartis: Consultancy, Speakers Bureau; Janssen: Honoraria, Research Funding; Pfizer: Speakers Bureau. Bigni: Janssen: Honoraria, Research Funding. Rodrigues: Janssen: Honoraria, Research Funding. Garicochea: Janssen: Honoraria, Research Funding. Pimenta: Janssen: Honoraria, Research Funding. Boechat: Janssen: Honoraria, Research Funding. Musacchio: Janssen: Honoraria, Research Funding. Goncalves: Janssen: Honoraria, Research Funding. Vieira: Janssen: Honoraria, Research Funding. Santos: Janssen: Employment. Grings: Janssen: Employment. Parisi: Janssen: Employment. Barreyro: Janssen: Employment.

Source: Blood - November 21, 2018 Category: Hematology Authors: Chiattone, C. S., Hamerschlak, N., Fogliatto, L., Scheinberg, P., Bigni, R., Rodrigues, C., Garicochea, B., Pimenta, A., Boechat, T. O., Musacchio, J., Bortolini, J., Goncalves, I. Z., Vieira, G. M. M., Buccheri, V., Santos, T., Grings, M., Parisi, L., Ba Tags: 642. CLL: Therapy, excluding Transplantation Source Type: research