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

NCT07145125 | Completed

• 1 other identifier: CHUBX 2024/60
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 5

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.

Conditions

Relapsed or Refractory Hodgkin Lymphoma

Keywords

R/R Hodgkin lymphoma; Brentuximab-vedotin

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) for the whole cohort

  Measured from the time of treatment initiation to the date of event : progression or death

  From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcomes (1)

• Overal survival (OS) for the whole cohort

  From date of inclusion until the date of death from any cause assessed up to 120 months

Study Arms (1)

Patient with relapsed or refractory Hodgkin Lymphoma

Drug: Brentuximab-Vedotin associated with Bendamustine

Interventions

Brentuximab-Vedotin associated with Bendamustine DRUG

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

Patient with relapsed or refractory Hodgkin Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with relapsed or refractory HL, after at least one first line of treatment

You may qualify if:

• 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

You may not qualify if:

• Minor patients
• Pregnant women

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CH de la Côte Basque, service Hématologie Clinique

Bayonne, France

Location

CHU de Bordeaux, service Hématologie Clinique et Thérapie cellulaire

Bordeaux, France

Location

CHU de Caen, service Hématologie Clinique

Caen, France

Location

Institut Paoli Calmettes, service Hématologie Clinique

Marseille, France

Location

CHU de Toulouse, service Hématologie Clinique

Toulouse, France

Location

MeSH Terms

Conditions

Recurrence; Hodgkin Disease

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: August 28, 2025
• Study Start: February 1, 2025
• Primary Completion: August 21, 2025
• Study Completion: September 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)