About this trial
This is a prospective, multicenter, phase II study, in elderly patients affected by Mantle cell lymphoma (MCL) defined as unfit/frail according to Simplified Geriatric Assessment (sGA) and previously untreated.
Patients will receive a treatment with Pirtobrutinib monotherapy until tumor progression, unacceptable adverse event, or patient decision for interruption.
Eligibility criteria
Qualifiers
Histologically documented diagnosis of nodal and extranodal mantle cell lymphoma (MCL) as defined in the 2022 edition of the World Health Organization (WHO) classification
Availability of biopsy material for central pathology revision and mutational analysis including TP53 (Tumor Protein p53) mutations
Age ≥ 70 years
Previously untreated MCL
Disqualifiers
Candidate to watch and wait due to indolent presentation
Leukemic non-nodal MCL that has stable asymptomatic disease should not be included in this study
Histological diagnosis different from MCL or leukemic non-nodal MCL
Fit patients according to sGA eligible to standard full dose therapy
Trial design
Treatments tested in this trial
- Pirtobrutinib