PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorFondazione Italiana Linfomi - ETS

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

Treatment groups

56 Participants
are divided into 1 treatment group