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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT07207785
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 6, 2025
Start date
Feb 1, 2026
Status verified
Sep 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2030

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Pirtobrutinib monotherapy in untreated elderly unfit/frail MCL patients.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 48 months ]

Central Contacts

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