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

Abrisqueta, Pau; González-Barca, Eva; Ferrà, Christelle; Ríos-Herranz, Eduardo; Fernández de la Mata, Margarita; Delgado, Julio; Andreu, Rafael; Hernández-Rivas, José Ángel; Terol, María José; Navarro, Almudena; Vidriales, M. Belén; Baltasar, Patricia; Serna, Javier de la; Ramírez, Ángel; Ballester, Carmen; Moreno, Carol; García-Marco, José Antonio; Córdoba, Raúl; Yáñez San Segundo, Lucrecia|||0000-0001-9925-3048

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, Pau, González-Barca, Eva, Ferrà, Christelle, Ríos-Herranz, Eduardo, Fernández de la Mata, Margarita, Delgado, Julio, Andreu, Rafael, Hernández-Rivas, José Ángel, Terol, María José, Navarro, Almudena, Vidriales, M. Belén, Baltasar, Patricia, Serna, Javier de la, Ramírez, Ángel, Ballester, Carmen, Moreno, Carol, García-Marco, José Antonio, Córdoba, Raúl, Yáñez San Segundo, Lucrecia\|\|\|0000-0001-9925-3048
Tipo de recurso:	artículo
Fecha de publicación:	2024
País:	España
Institución:	Universidad de Cantabria (UC)
Repositorio:	UCrea Repositorio Abierto de la Universidad de Cantabria
Idioma:	inglés
OAI Identifier:	oai:repositorio.unican.es:10902/33814
Acceso en línea:	https://hdl.handle.net/10902/33814
Access Level:	acceso abierto
Palabra clave:	Chronic lymphocytic leukemia Treatment Consolidation

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spelling	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)Abrisqueta, PauGonzález-Barca, EvaFerrà, ChristelleRíos-Herranz, EduardoFernández de la Mata, MargaritaDelgado, JulioAndreu, RafaelHernández-Rivas, José ÁngelTerol, María JoséNavarro, AlmudenaVidriales, M. BelénBaltasar, PatriciaSerna, Javier de laRamírez, ÁngelBallester, CarmenMoreno, CarolGarcía-Marco, José AntonioCórdoba, RaúlYáñez San Segundo, Lucrecia\|\|\|0000-0001-9925-3048Chronic lymphocytic leukemiaTreatmentConsolidationBackground: 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.Funding: The study was funded by Janssen that also supplied ibrutinib, whereas ofatumumab was supplied by Novartis. Acknowledgements: The authors thank the patients for their participation. The study was funded by Janssen that also supplied ibrutinib, whereas ofatumumab was supplied by Novartis. This work was also supported in part by the Instituto de Salud Carlos III, Fondo de Investigaciones Sanitarias (PI17/00943, PI18/01392, PI22/01204), Gilead Sciences (GLD15/00348, M.G) and the Health Council of the Junta de Castilla y León (GRS 2036/A/19, M.G.).ElsevierUniversidad de Cantabria20242024-01-01journal articlehttp://purl.org/coar/resource_type/c_6501NAhttp://purl.org/coar/version/c_be7fb7dd8ff6fe43info:eu-repo/semantics/articlehttps://hdl.handle.net/10902/33814eClinicalMedicine, 2024, 73, 102642reponame:UCrea Repositorio Abierto de la Universidad de Cantabriainstname:Universidad de Cantabria (UC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositorio.unican.es:10902/338142026-06-02T12:39:31Z
dc.title.none.fl_str_mv	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
title	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
spellingShingle	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC) Abrisqueta, Pau Chronic lymphocytic leukemia Treatment Consolidation
title_short	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
title_full	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
title_fullStr	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
title_full_unstemmed	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
title_sort	Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)
dc.creator.none.fl_str_mv	Abrisqueta, Pau González-Barca, Eva Ferrà, Christelle Ríos-Herranz, Eduardo Fernández de la Mata, Margarita Delgado, Julio Andreu, Rafael Hernández-Rivas, José Ángel Terol, María José Navarro, Almudena Vidriales, M. Belén Baltasar, Patricia Serna, Javier de la Ramírez, Ángel Ballester, Carmen Moreno, Carol García-Marco, José Antonio Córdoba, Raúl Yáñez San Segundo, Lucrecia\|\|\|0000-0001-9925-3048
author	Abrisqueta, Pau
author_facet	Abrisqueta, Pau González-Barca, Eva Ferrà, Christelle Ríos-Herranz, Eduardo Fernández de la Mata, Margarita Delgado, Julio Andreu, Rafael Hernández-Rivas, José Ángel Terol, María José Navarro, Almudena Vidriales, M. Belén Baltasar, Patricia Serna, Javier de la Ramírez, Ángel Ballester, Carmen Moreno, Carol García-Marco, José Antonio Córdoba, Raúl Yáñez San Segundo, Lucrecia\|\|\|0000-0001-9925-3048
author_role	author
author2	González-Barca, Eva Ferrà, Christelle Ríos-Herranz, Eduardo Fernández de la Mata, Margarita Delgado, Julio Andreu, Rafael Hernández-Rivas, José Ángel Terol, María José Navarro, Almudena Vidriales, M. Belén Baltasar, Patricia Serna, Javier de la Ramírez, Ángel Ballester, Carmen Moreno, Carol García-Marco, José Antonio Córdoba, Raúl Yáñez San Segundo, Lucrecia\|\|\|0000-0001-9925-3048
author2_role	author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Universidad de Cantabria
dc.subject.none.fl_str_mv	Chronic lymphocytic leukemia Treatment Consolidation
topic	Chronic lymphocytic leukemia Treatment Consolidation
description	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.
publishDate	2024
dc.date.none.fl_str_mv	2024 2024-01-01
dc.type.none.fl_str_mv	journal article http://purl.org/coar/resource_type/c_6501 NA http://purl.org/coar/version/c_be7fb7dd8ff6fe43
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://hdl.handle.net/10902/33814
url	https://hdl.handle.net/10902/33814
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Elsevier
publisher.none.fl_str_mv	Elsevier
dc.source.none.fl_str_mv	eClinicalMedicine, 2024, 73, 102642 reponame:UCrea Repositorio Abierto de la Universidad de Cantabria instname:Universidad de Cantabria (UC)
instname_str	Universidad de Cantabria (UC)
reponame_str	UCrea Repositorio Abierto de la Universidad de Cantabria
collection	UCrea Repositorio Abierto de la Universidad de Cantabria
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Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC)

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