This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.
Adult patients (≥18 years of age).
Written informed consent must be obtained before any study-specific assessment is performed.
Subjects with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022] or World Health Organization (WHO) Classification 2022. Classical, small-cell variants and marginal-zone variants can be included.
Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)
Subjects with aggressive histological variants: blastoid and pleomorphic variants of MCL
B-cell monoclonal lymphocytosis with MCL phenotype
Presence of B symptoms or any relevant symptoms related to the MCL.
Nodal clinical forms with lymph node enlargement > 3 cm (largest diameter).
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead sponsor
Evidenze CRO
Collaborator
Eli Lilly and Company
Collaborator