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Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting — FIL-BBV  

Lymphatic Diseases Clinical Trial

Official title:
A Phase II Study With Bendamustine Plus Brentuximab Vedotin in Hodgkin's Lymphoma and CD30+ Peripheral T-cell Lymphoma in First Salvage Setting: the BBV Regimen.

Clinical Trial Summary

This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL. A total of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated according to this treatment protocol.

Clinical Trial Description

In the study, intravenous bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 and brentuximab will be given intravenously at a total dose of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6 cycles. All patients achieving a CR can be considered eligible to peripheral blood stem cell mobilization (to be performed with granulocytecolony stimulating factor alone) and may proceed to an ASCT at any time after cycle 4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02499627
Study type Interventional
Source Fondazione Italiana Linfomi ONLUS
Contact
Status Terminated
Phase Phase 2
Start date December 23, 2015
Completion date June 30, 2020
View Details
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