Observational
Otherobservational
NCT Number: NCT06295211
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.
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Notify Me18 year–60 year
All sexes
Observational
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 1.8 mg/kg 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 mg/m2 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
observational
Time frame: 10 year period
survival
Time frame: 10 year period
survival
Time frame: at end of 4 cycles treatment (each cycle of 28 days)
Complete Metabolic Remission rate
Time frame: during 4 cycles of treatment (each cycle of 28 days)
side effect to regimen related to both Brentuximab and bendamustine
Federico II University
Other
Acronym: HL_PR/R-B
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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