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.
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
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
Single group
Pirtobrutinib
DrugPatients will receive pirtrobrutinib at a starting dose of 200 mg once daily (q.d). All treatment will be administered orally and a cycle will be defined as 28 days in length and should be maintained regardless of dose interruptions. Treatment is meant to be administered until tumor progression, unacceptable adverse event, or patient decision for interruption.
Progression Free Survival (PFS)
PFS defined as the time between the start of treatment and the first documentation of recurrence, progression or death for any cause
Overall response rate (ORR)
Overall Response Rate (ORR) will be defined as the proportion of patients achieving either a Complete Response (CR) or a Partial Response (PR), according to the Lugano 2014 criteria for response assessment in lymphoma.
Complete response rate (CRR)
Complete response rate (CRR) refers to the proportion of patients whose disease completely disappears following treatment, as determined by clinical, imaging, or pathological assessments. It indicates a full remission of detectable disease.
Overall survival (OS)
Overall survival (OS) is defined as the time between the start of treatment and death from any cause
Event free survival (EFS)
Event free survival (EFS) is defined as the time between the start of treatment and treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
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This trial is not recruiting at the moment. You can still explore other options:
