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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.
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 1, 2013
Primary Completion Date
September 1, 2023
Completion Date
February 22, 2024
Last Updated
March 6, 2024
32
ACTUAL participants
observational
OTHER
Lead Sponsor
Federico II University
NCT05529069
NCT06189391
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05006716