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

NCT07207785 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Carlo Visco, Prof. · Verona - AOU Integrata di Verona - U.O. Ematologia

  • Guido Gini, Dott. · Ancona - AOU Ospedali Riuniti - Clinica di Ematologia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2030-02-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207785 on ClinicalTrials.gov