Clinical trial · Observational
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.
NCT06295211CI-TRIAL-00074714HL_PR/R-BcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 10 year period
- description
- survival
Secondary outcomes (3)
- measure
- Progression overall survival
- timeFrame
- 10 year period
- description
- survival
- measure
- Response to treatment
- timeFrame
- at end of 4 cycles treatment (each cycle of 28 days)
- description
- Complete Metabolic Remission rate
- measure
- Incidence of treatment emergent adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTPicardi 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
- RESULTCheson 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