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jco.21.02321.pdf (274.93 KB)

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2022-01-14

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cc by-nc-nd (c) Giné, Eva et al., 2022
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/187044

Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial

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https://doi.org/10.1200/JCO.21.02321

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PURPOSE The need for an individualized management of indolent clinical forms in mantle cell lymphoma (MCL) is increasingly recognized. We hypothesized that a tailored treatment with ibrutinib in combination with rituximab (IR) could obtain significant responses in these patients. METHODS This is a multicenter single-arm, open-label, phase II study with a two-stage design conducted in 12 Spanish GELTAMO sites (ClinicalTrials.gov identifier: NCT02682641). Previously untreated MCL patients with indolent clinical forms defined by the following criteria were eligible: no disease-related symptoms, nonblastoid variants, Ki-67 < 30%, and largest tumor diameter <= 3 cm. Both leukemic non-nodal and nodal subtypes were recruited. Patients received ibrutinib 560 mg once daily and a total of eight doses of rituximab 375 mg/m(2). Ibrutinib could be discontinued after 2 years in the case of sustained undetectable minimal residual disease (MRD). The primary end point was the complete response (CR) rate achieved after 12 cycles according to Lugano criteria. RESULTS Fifty patients with MCL (male 66%; median age 65 years) were enrolled. After 12 cycles of treatment, 42 (84%; 95% CI, 74 to 94) patients had an overall response, including 40 (80%; 95% CI, 69 to 91) with CR. Moreover, undetectable MRD in peripheral blood was achieved in 87% (95% CI, 77 to 97) of cases. At 2 years, 24 of 35 evaluable patients (69%) could discontinue ibrutinib because of undetectable MRD. Four patients had disease progression; three were non-nodal MCL and carried high genomic complexity and TP53 mutations at enrollment. No unexpected toxicity was seen except one patient with severe aplastic anemia. CONCLUSION Frontline IR combination achieves a high rate of CRs and undetectable MRD in indolent clinical forms of MCL. Discontinuation seems appropriate in cases with undetectable MRD, except for TP53-mutated cases.

Matèries

Rituximab, Limfomes, Assaigs clínics

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Rituximab, Lymphomas, Clinical trials

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Citació

GINÉ SOCA, Eva, CRUZ, Fátima de la, JIMÉNEZ UBIETO, Ana, LÓPEZ JIMENEZ, Javier, MARTÍN GARCÍA-SANCHO, Alejandro, TEROL, M. josé, GONZÁLEZ BARCA, Eva, CASANOVA, María, FUENTE, Adolfo de la, MARÍN NIEBLA, Ana, MUNTAÑOLA, Ana, GONZÁLEZ LÓPEZ, Tomás josé, AYMERICH GREGORIO, Marta, SETOAIN PEREGO, Xavier, CORTÉS ROMERA, Montserrat, ROTGER, Amanda, RODRÍGUEZ, Sonia, MEDINA HERRERA, Alejandro, GARCÍA SANZ, Ramón, NADEU PRAT, Ferran, BEÀ BOBET, Sílvia m., CAMPO GÜERRI, Elias, LÓPEZ GUILLERMO, Armando, The GELTAMO Group. Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial. _Journal of Clinical Oncology_. 2022. Vol. 40, núm. 11, pàgs. 1196-1205. [consulta: 21 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/187044]

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