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.

NCT06295211 | Completed

• 1 other identifier: FEDII_HL_PR/R-Bv-Bs
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; primary refractory; bendamustine supercharge; brentuximab vedotin

Outcome Measures

Primary Outcomes (1)

• Overall survival

  survival

  10 year period

Secondary Outcomes (3)

• Progression overall survival

  10 year period

• Response to treatment

  at end of 4 cycles treatment (each cycle of 28 days)

• Incidence of treatment emergent adverse events

  during 4 cycles of treatment (each cycle of 28 days)

Interventions

observational OTHER

observational

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

Sponsors & Collaborators

• Federico II University: lead

Related Publications (2)

• 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 lymphoma. Blood Adv. 2019 May 14;3(9):1546-1552. doi: 10.1182/bloodadvances.2019000123.

  PMID: 31088808 RESULT

• 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/blood-2016-05-718528. Epub 2016 Aug 29.

  PMID: 27574190 RESULT

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 6, 2024
• Study Start: September 1, 2013
• Primary Completion: September 1, 2023
• Study Completion: February 22, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share