%0 Journal Article
%A Giné, Eva
%A de la Cruz, Fátima
%A Jiménez Ubieto, Ana
%A López Jimenez, Javier
%A Martín García-Sancho, Alejandro
%A Terol, M José
%A González Barca, Eva
%A Casanova, María
%A de la Fuente, Adolfo
%A Marín-Niebla, Ana
%A Muntañola, Ana
%A González-López, Tomás José
%A Aymerich, Marta
%A Setoain, Xavier
%A Cortés-Romera, Montserrat
%A Rotger, Amanda
%A Rodríguez, Sonia
%A Medina Herrera, Alejandro
%A García Sanz, Ramón
%A Nadeu, Ferran
%A Beà, Silvia
%A Campo, Elías
%A López-Guillermo, Armando
%T Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.
%D 2022
%U http://hdl.handle.net/10668/20388
%X 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. 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  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. 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.
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