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

Conditions

Mantle Cell Lymphoma

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGPIRTOBRUTINIB

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 Can	—

Measure

Time frame

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 Can

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Outcome results

None listed