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 consolidation...

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Autores: Abrisqueta P, González-Barca E, Ferrà C, Ríos-Herranz E, Fernández de la Mata M, Delgado J, Andreu R, Hernández-Rivas JÁ, Terol MJ, Navarro A, Vidriales MB, Baltasar P, De la Serna J, Ramírez Á, Ballester C, Moreno C, García-Marco JA, Córdoba R, Yáñez L, Casado LF, González M, Bosch F
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p19125
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/19125
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 PGonzález-Barca EFerrà CRíos-Herranz EFernández de la Mata MDelgado JAndreu RHernández-Rivas JÁTerol MJNavarro AVidriales MBBaltasar PDe la Serna JRamírez ÁBallester CMoreno CGarcía-Marco JACórdoba RYáñez LCasado LFGonzález MBosch FChronic 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 fi ndings 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.<br /> Funding The study was funded by Janssen that also supplied ibrutinib, whereas ofatumumab was supplied by Novartis. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).ELSEVIER2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/19125EClinicalMedicineISSN: 25895370reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p191252026-06-07T16:35:31Z
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 P
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 P
González-Barca E
Ferrà C
Ríos-Herranz E
Fernández de la Mata M
Delgado J
Andreu R
Hernández-Rivas JÁ
Terol MJ
Navarro A
Vidriales MB
Baltasar P
De la Serna J
Ramírez Á
Ballester C
Moreno C
García-Marco JA
Córdoba R
Yáñez L
Casado LF
González M
Bosch F
author Abrisqueta P
author_facet Abrisqueta P
González-Barca E
Ferrà C
Ríos-Herranz E
Fernández de la Mata M
Delgado J
Andreu R
Hernández-Rivas JÁ
Terol MJ
Navarro A
Vidriales MB
Baltasar P
De la Serna J
Ramírez Á
Ballester C
Moreno C
García-Marco JA
Córdoba R
Yáñez L
Casado LF
González M
Bosch F
author_role author
author2 González-Barca E
Ferrà C
Ríos-Herranz E
Fernández de la Mata M
Delgado J
Andreu R
Hernández-Rivas JÁ
Terol MJ
Navarro A
Vidriales MB
Baltasar P
De la Serna J
Ramírez Á
Ballester C
Moreno C
García-Marco JA
Córdoba R
Yáñez L
Casado LF
González M
Bosch F
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
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 fi ndings 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.<br /> Funding The study was funded by Janssen that also supplied ibrutinib, whereas ofatumumab was supplied by Novartis. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/19125
url https://incliva.portalinvestigacion.com/publicaciones/19125
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
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
ISSN: 25895370
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
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