NCT04913103

Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL

A Phase II, Open-label Study of Polatuzumab-vedotin (PV) in Combination With Bendamustine and Rituximab for Patients With Mantle Cell Lymphoma, Who Relapse After Previous Therapy With Bruton Tyrosine Kinase Inhibitor

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Czech Lymphoma Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor

Detailed description

Primary objective: Efficacy: to evaluate the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS) Secondary objectives: Efficacy: to evaluate the efficacy of polatuzumab vedotin plus BR with respect to secondary efficacy endpoints, namely overall response rate, duration of response, event free survival and overall survival; Safety objective; Exploratory objectives

Conditions

• Lymphoma, Mantle-Cell

Interventions

Type	Name	Description
DRUG	Polatuzumab vedotin	treatment by a study drug polatuzumab-vedotin, i.v.
DRUG	Bendamustine Hydrochloride	treatment by a study drug bendamustin i.v.
DRUG	Rituximab	treatment by a study drug rituximab, i.v.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2021-06-04
• Last updated: 2021-06-04

Locations

7 sites across 1 country: Czechia