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Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL-R2-B2)

Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07145125
Acronym
HL-R2-B2
Enrollment
222
Registered
2025-08-28
Start date
2025-02-01
Completion date
2025-09-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Hodgkin Lymphoma

Keywords

R/R Hodgkin lymphoma, Brentuximab-vedotin

Brief summary

Approximately 20% of patients diagnosed with Hodgkin lymphoma will eventually experience progression or relapse after first-line treatment, which carries a significant risk of disease-related death. Although several pilot studies have demonstrated high rates of sustained response with the combination of brentuximab vedotin (BV) and chemotherapy, consistent real-world data are still lacking. Moreover, there is no universally accepted salvage chemotherapy regimen in this setting, and clinical practices vary across centers. This study aims to describe the efficacy and toxicity of the BV + bendamustine (B2) regimen in patients with relapsed/refractory Hodgkin lymphoma (R/R HL) treated in France over a 10-year period, with or without an attempt at consolidative transplantation.

Detailed description

This study is a retrospective observational multicentric study. All patients fulfilling inclusion criteria in participant centers will be included. Clinical data will be obtained from patients medical records.

Interventions

DRUGBrentuximab-Vedotin associated with Bendamustine

Patient having received at least one course of the association Brentuximab-Vedotin and Bendamustine

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with relapsed or refractory HL, after at least one first line of treatment * Aged 18 years and over * Having received at least one course of the Brenxutimab-Vedotin J1 and Bendamustine J1 + J2 combination

Exclusion criteria

* Minor patients * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Progression free survival (PFS) for the whole cohortFrom date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 monthsMeasured from the time of treatment initiation to the date of event : progression or death

Secondary

MeasureTime frameDescription
Overal survival (OS) for the whole cohortFrom date of inclusion until the date of death from any cause assessed up to 120 monthsMeasured from the time of treatment initiation to the date of death

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026