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Clinical Trial Summary

This is a multicentric single arm phase II trial, to investigate the efficacy (in terms of PFS) of the combination regimen rituximab-bendamustine in association with copanlisib in patients affected by relapsed/refractory DLBCL, not eligible to HDC and ASCT or relapsed after intensified regimens.


Clinical Trial Description

The primary objective of this study is to evaluate the efficacy, in terms of Progression Free Survival (12m-PFS) at 12 months, of a treatment with copanlisib in combination with a standard rituximab-bendamustine regimen in patients with relapsed-refractory DLBCL, who have received at least one, but no more than three lines of treatment, including rituximab-based immunochemotherapy, not eligible for high-dose chemotherapy and ASCT or T-cell CAR-T therapy, or relapsed after these treatments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04433182
Study type Interventional
Source Fondazione Italiana Linfomi - ETS
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 18, 2020
Completion date August 1, 2024

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