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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Capability of understanding the purpose of the study and have given written informed consent.

• Age greater than or equal to 18 years

• Histologically or cytologically confirmed relapsed or refractory MCL

• r/r MCL patients following standard first line chemotherapy who have received at least one prior regimen including ibrutinib

• If the participant has received prior bendamustine, response duration must have been \> 1 year

• Presence of at least one lymph node or mass measurable for response

• Life expectancy of at least 24 weeks

• ECOG 0-2

• Adequate hematological, renal and hepatic function unless inadequate function is due to underlying disease

Locations
Other Locations
Austria
AKH Vienna, Division of Oncology Department of Medicine I
RECRUITING
Vienna
Contact Information
Primary
Barbara Kiesewetter, MD
barbara.kiesewetter@meduniwien.ac.at
+43140400
Backup
Marika Rosner
marika.rosner@meduniwien.ac.at
+43140400
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2027-05-24
Participants
Target number of participants: 16
Treatments
Experimental: Polatuzumab, bendamustine and 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 and rituximab 375 mg/m2 i.v. on day 1 of each cycle every 3 weeks.
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov

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