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Title: | Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial |
Author: | 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, Ferran Beà Bobet, Sílvia M. Campo Güerri, Elias López Guillermo, Armando The GELTAMO Group |
Keywords: | Rituximab Limfomes Assaigs clínics Rituximab Lymphomas Clinical trials |
Issue Date: | 14-Jan-2022 |
Publisher: | American Society of Clinical Oncology (ASCO) |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1200/JCO.21.02321 |
It is part of: | Journal of Clinical Oncology, 2022, vol. 40, num. 11, p. 1196-1205 |
URI: | http://hdl.handle.net/2445/187044 |
Related resource: | https://doi.org/10.1200/JCO.21.02321 |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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