Miniatura

Fitxers

908610.pdf (600.82 KB)

Tipus de document

Article

Versió

Versió publicada

Data de publicació

2024-05-25

Llicència de publicació

cc-by-nc-nd (c) Abrisqueta, Pau et al., 2024
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/224956

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

Títol de la revista

Autors

Director/Tutor

ISSN de la revista

Títol del volum

Recurs relacionat

https://doi.org/10.1016/j.eclinm.2024.102642

Resum

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.

Matèries

Quimioteràpia del càncer, Medicaments antineoplàstics, Leucèmia limfocítica crònica

Matèries (anglès)

Cancer chemotherapy, Antineoplastic agents, Chronic lymphocytic leukemia

Citació

Col·leccions

Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

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. Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC). _eClinicalMedicine_. 2024. Vol. 73. [consulta: 9 de gener de 2026]. ISSN: 2589-5370. [Disponible a: https://hdl.handle.net/2445/224956]

Exportar metadades

JSON - METS

Compartir registre