NCT05868395

Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma

Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma

Detailed description

Polatuzumab vedotin will be administered at a dose of 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle. Bendamustine will be administered at a dose 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle. Rituximab will be administered at a dose 375 mg/m2 i.v. on day 1 of each cycle. Each cycle is 21 days long Response rate by RECIST 1.1 is definied as the primary study endpoint.

Conditions

• Mantle-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Polatuzumab, bendamustin und rituximab	* Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle * Bendamustine 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle * Rituximab 375 mg/m2 i.v. on day 1 of each cycle * Each cycle is 21 days long * Up to 6 cycles per patients planned

Timeline

• Start date: 2024-01-02
• Primary completion: 2027-05-24
• Completion: 2027-05-24
• First posted: 2023-05-22
• Last updated: 2024-05-29

Locations

1 site across 1 country: Austria