Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295211
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-23
Brief Title:
Brentuximab Vedotin Combined With Bendamustine Supercharge a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma Long-term Results of a Retrospective Monocenter Study
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Brentuximab Vedotin Combined With Bendamustine Supercharge a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma Long-term Results of a Retrospective Monocenter Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
HL_PRR-B
Brief Summary:
This is a retrospective monocenter and non-interventional study Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023
Detailed Description:
This is a retrospective monocenter and non-interventional study Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023
The regimen consisted of 3-day outpatient intravenous infusions of 18 mgkg Bv on Day 1 of each 3-week cycle as established by Younes and colleagues sequentially combined with bendamustine at least 24 hours after Bv precisely on days 2 and 3 of the treatment cycle as reported by Picardi et al at a fixed dose of 120 mgm2 per day
All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell PBSC collection performed with granulocyte colony-stimulating factor G-CSF and endoxan or plerixafor if necessary and proceeded to ASCT at any time beyond cycle 4
The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment
Prior to the first cycle of Bv-Bs all patients underwent a clinical evaluation that included assessment of B symptoms World Health Organization performance status and measurement of palpable lesions In particular imaging procedures were conducted after the second and fourth cycles or prior to ASCT The response was based on international criteria Cheson et al 2016 PET scans were considered positive or negative based on the Deauville 5-point scale criteria
The regimen consisted of 3-day outpatient intravenous infusions of 18 mgkg Bv on Day 1 of each 3-week cycle as established by Younes and colleagues sequentially combined with bendamustine at least 24 hours after Bv precisely on days 2 and 3 of the treatment cycle as reported by Picardi et al at a fixed dose of 120 mgm2 per day
All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell PBSC collection performed with granulocyte colony-stimulating factor G-CSF and endoxan or plerixafor if necessary and proceeded to ASCT at any time beyond cycle 4
The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment
Prior to the first cycle of Bv-Bs all patients underwent a clinical evaluation that included assessment of B symptoms World Health Organization performance status and measurement of palpable lesions In particular imaging procedures were conducted after the second and fourth cycles or prior to ASCT The response was based on international criteria Cheson et al 2016 PET scans were considered positive or negative based on the Deauville 5-point scale criteria
Study Oversight
Has Oversight DMC:
None
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?:
None