Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 2:43 AM
Study NCT ID:
NCT05868395
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: