RT Journal Article
T1 Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.
A1 Giné, Eva
A1 de la Cruz, Fátima
A1 Jiménez Ubieto, Ana
A1 López Jimenez, Javier
A1 Martín García-Sancho, Alejandro
A1 Terol, M José
A1 González Barca, Eva
A1 Casanova, María
A1 de la Fuente, Adolfo
A1 Marín-Niebla, Ana
A1 Muntañola, Ana
A1 González-López, Tomás José
A1 Aymerich, Marta
A1 Setoain, Xavier
A1 Cortés-Romera, Montserrat
A1 Rotger, Amanda
A1 Rodríguez, Sonia
A1 Medina Herrera, Alejandro
A1 García Sanz, Ramón
A1 Nadeu, Ferran
A1 Beà, Silvia
A1 Campo, Elías
A1 López-Guillermo, Armando
AB 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.
YR 2022
FD 2022-01-14
LK http://hdl.handle.net/10668/20388
UL http://hdl.handle.net/10668/20388
LA en
DS RISalud
RD Apr 20, 2025