Publication: Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.
Identifiers
Date
2022-01-14
Authors
Giné, Eva
de la Cruz, Fátima
Jiménez Ubieto, Ana
López Jimenez, Javier
Martín García-Sancho, Alejandro
Terol, M José
González Barca, Eva
Casanova, María
de la Fuente, Adolfo
Marín-Niebla, Ana
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Abstract
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.
Description
MeSH Terms
Adenine
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Humans
Lymphoma, Mantle-Cell
Male
Neoplasm, Residual
Piperidines
Rituximab
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Humans
Lymphoma, Mantle-Cell
Male
Neoplasm, Residual
Piperidines
Rituximab