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

NCT ID: NCT07145125

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Relapsed or Refractory Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with relapsed or refractory Hodgkin Lymphoma

Brentuximab-Vedotin associated with Bendamustine

Intervention Type DRUG

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

Interventions

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Brentuximab-Vedotin associated with Bendamustine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de la Côte Basque, service Hématologie Clinique

Bayonne, , France

Site Status

CHU de Bordeaux, service Hématologie Clinique et Thérapie cellulaire

Bordeaux, , France

Site Status

CHU de Caen, service Hématologie Clinique

Caen, , France

Site Status

Institut Paoli Calmettes, service Hématologie Clinique

Marseille, , France

Site Status

CHU de Toulouse, service Hématologie Clinique

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2024/60

Identifier Type: -

Identifier Source: org_study_id

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