NCT02499627

Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphatic Diseases

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	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.
DRUG	Bendamustine	Bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 of each 21 days-based cycle, for 6 cycles.

Timeline

• Start date: 2015-12-23
• Primary completion: 2019-09-13
• Completion: 2020-06-30
• First posted: 2015-07-16
• Last updated: 2021-05-27

Locations

5 sites across 1 country: Italy