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.

Hodgkin Lymphoma Clinical Trial

— HL_PR/R-B  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06295211
• Other study ID #: FEDII_HL_PR/R-Bv-Bs
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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)