NCT07207785

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

PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma: a Phase II Study of the Fondazione Italiana Linfomi (FIL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

After providing written informed consent, patients will be evaluated for eligibility during a 28-day screening period. Patients will receive pirtobrutinib at a starting dose of 200 mg once daily (2 tablets 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. Responses shall be assessed at month +3, +6 after start of treatment and then every 6 months using the radiologic method of tumor assessment consistent throughout the study and aligned with the baseline method (CT scan or ultrasound echography are acceptable). Positron Emission Tomography (PET) scan is mandatory at baseline and at month +3 after start of treatment to establish tumor response.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Patients 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

20 sites across 1 country: Italy