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. (HL_PR/R-B)

Federico II University

Status: Completed

Conditions: Hodgkin Lymphoma

Treatments: Other: observational

Study type: Observational

Funder types: Other

Identifiers

NCT06295211

FEDII_HL_PR/R-Bv-Bs

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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