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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06295211
Other study ID # FEDII_HL_PR/R-Bv-Bs
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2013
Est. completion date February 22, 2024

Study information

Verified date March 2024
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date February 22, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - patients age between 18 years and 60 years; - histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment [after 2 cycles of ABVD] with interim FDG-PET/CT with Deauville scale score of 5 [primary refractory patients]) - treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively - metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT) - EGOG performance status 0-2 (or 3, if due to illness). Exclusion Criteria: - patients not fulfilling inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observational
observational

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

References & Publications (2)

Cheson BD, Ansell S, Schwartz L, Gordon LI, Advani R, Jacene HA, Hoos A, Barrington SF, Armand P. Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy. Blood. 2016 Nov 24;128(21):2489-2496. doi: 10.1182 — View Citation

Picardi M, Della Pepa R, Giordano C, Pugliese N, Mortaruolo C, Trastulli F, Rascato MG, Cappuccio I, Raimondo M, Memoli M, Monteverde M, Mascolo M, Pane F. Brentuximab vedotin followed by bendamustine supercharge for refractory or relapsed Hodgkin lymphom — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival survival 10 year period
Secondary Progression overall survival survival 10 year period
Secondary Response to treatment Complete Metabolic Remission rate at end of 4 cycles treatment (each cycle of 28 days)
Secondary Incidence of treatment emergent adverse events side effect to regimen related to both Brentuximab and bendamustine during 4 cycles of treatment (each cycle of 28 days)
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