Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-23 @ 11:09 PM
Study NCT ID:
NCT02499627
Status:
TERMINATED
Last Update Posted:
2021-05-27
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting
Sponsor:
Fondazione Italiana Linfomi - ETS
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
expected accrual not reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIL-BBV
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: