PirtobrUtinib as frontline Therapy for elderly unfit/frail patient with MAntle cell lymphoma: a phase II study of the Fondazione Italiana Linfomi (FIL)

Condition studied

Mantle Cell Lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

PFS defined as the time between the start of treatment and the first documentation of recurrence, progression or death for any cause

Endpoint detail

Overall response rate [ORR = complete response (CR) + partial response (PR) rate) (according to Lugano, 2014 criteria)], Complete response rate (CRR), Overall survival (OS) defined as the time between the start of treatment and death from any cause, Event free survival (EFS) 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), Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression or death from any cause, Drop-out rate, Rate of treatment discontinuation due to AE or treatment intolerance, Frequency and severity of AEs and SAEs classified as per latest version of CTCAE, The health-related quality of life (HRQoL) as measured by the EuroQol 5-Dimension Scale (EQ-5D-5L) and the Functional Assessment of Cancer Therapy for Patients with Lymphoma (FACTLym) standardized questionnaire on health status