Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)

Background: BTK inhibitors have been concurrently administered with anti-CD20 monoclonal antibodies (mAbs) in chronic lymphocytic leukemia (CLL). However, the optimal regimen for combining these two drugs remains pending. Methods: This multi-center phase 2 study aimed to analyze whether consolidatio...

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Detalles Bibliográficos
Autores: Abrisqueta Costa, Pau, González Barca, Eva, Ferrà, Christelle, Rios-Herranz, Eduardo, Fernández de la Mata, Margarita, Delgado, Julio (Delgado González), Andreu, Rafael, Hernandez Rivas, Jose Angel, Terol, María José, Navarro-Bailón, Almudena, Vidriales, Belén, Baltasar, Patricia, De la Serna, Javier, Ramírez, Ángel, Ballester, Carmen, Moreno, Carol, García-Marco, José Antonio, Córdoba, Raúl, Yáñez, Lucrecia, Casado, Luís Felipe, González, Marcos, Bosch Albareda, Francesc
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/224956
Acceso en línea:https://hdl.handle.net/2445/224956
Access Level:acceso abierto
Palabra clave:Quimioteràpia del càncer
Medicaments antineoplàstics
Leucèmia limfocítica crònica
Cancer chemotherapy
Antineoplastic agents
Chronic lymphocytic leukemia
Descripción
Sumario:Background: BTK inhibitors have been concurrently administered with anti-CD20 monoclonal antibodies (mAbs) in chronic lymphocytic leukemia (CLL). However, the optimal regimen for combining these two drugs remains pending. Methods: This multi-center phase 2 study aimed to analyze whether consolidation with ofatumumab improved the response in patients with CLL receiving front-line treatment with ibrutinib. Patients received 12 cycles of ibrutinib monotherapy. Those who achieved CR after this induction were maintained on ibrutinib. Conversely, those who did not attain CR continued with ibrutinib in addition to a consolidation, which involved 7 doses of ofatumumab. The primary objective was the complete response (CR) rate at cycle 20. This study is registered within the EU Clinical Trials Register (EudraCT 2016-004937-26). Findings: Between September 8, 2017, and May 21, 2018, 84 patients (median age, 69 years) were included. After completion of 12 cycles of ibrutinib (n = 80), 4 patients (5%) were in CR, 67 (84%) in partial response (PR), and 6 patients (7%) had a PR with lymphocytosis (PRL). After consolidation with ofatumumab, 20 patients improved the response from PR to CR and 6 patients with PRL obtained a PR. Seventy-one patients (85%) completed 20 cycles of treatment, with a CR rate of 24/71 (34%). According to the intention-to-treat analysis at cycle 20, the ORR was 69/84 (82.2%), with a CRR of 24/84 (28.6%). Progression-free survival and overall survival at 48-months were 89.9% (CI: 82.4-95.5) and 92.2% (CI: 85.3-97.1), respectively. Interpretation: These findings underscore the potential for a consolidation strategy in CLL, wherein the addition of a mAb in patients with low tumor burden might enhance the quality of the response.

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