NCT07145125

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
• Phase: —
• Study type: Observational
• Enrollment: 222 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab-Vedotin associated with Bendamustine	Patient having received at least one course of the association Brentuximab-Vedotin and Bendamustine

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-08-21
• Completion: 2025-09-30
• First posted: 2025-08-28
• Last updated: 2025-11-21

Locations

5 sites across 1 country: France