Relapsed or Refractory Hodgkin LymphomaHL-R2-B2NCT07145125
Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL-R2-B2)
An observational study of Relapsed or Refractory Hodgkin Lymphoma, run by University Hospital, Bordeaux at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Hodgkin Lymphoma
- What is being tested?
- Brentuximab-Vedotin associated with Bendamustine
- How many people
- 222 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Feb 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with relapsed or refractory HL, after at least one first line of treatment
Who may be able to join
- 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
Who cannot join
- Minor patients
- Pregnant women
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH de la Côte Basque, service Hématologie Clinique
Bayonne
CHU de Bordeaux, service Hématologie Clinique et Thérapie cellulaire
Bordeaux
CHU de Caen, service Hématologie Clinique
Caen
Institut Paoli Calmettes, service Hématologie Clinique
Marseille
CHU de Toulouse, service Hématologie Clinique
Toulouse
About this study
Official title: Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma
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.
Read the 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
- Being tested
- Brentuximab-Vedotin associated with Bendamustine
- Keywords
- R/R Hodgkin lymphoma, Brentuximab-vedotin
- Medical subject headings
- Recurrence, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab-Vedotin associated with BendamustineDrug
Patient having received at least one course of the association Brentuximab-Vedotin and Bendamustine
| Study group | Role | What they receive |
|---|---|---|
| Patient with relapsed or refractory Hodgkin Lymphoma | Not described Receives: Drug: Brentuximab-Vedotin associated with Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) for the whole cohort
Measured from the time of treatment initiation to the date of event : progression or death
Measured: 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
Measured from the time of treatment initiation to the date of death
Measured: From date of inclusion until the date of death from any cause assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Feb 2025
- Primary completion21 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145125
- Sponsor's protocol ID
- CHUBX 2024/60
- Acronym
- HL-R2-B2
- Status last verified
- Nov 2025
- First submitted
- 18 Mar 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Efficacy and Toxicity of Brentuximab-Vedotin Associated With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07145125
- Acronym / sponsor ID
- HL-R2-B2 / CHUBX 2024/60
- Conditions
- Relapsed or Refractory Hodgkin Lymphoma
- Keywords
- R/R Hodgkin lymphoma, Brentuximab-vedotin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with relapsed or refractory Hodgkin Lymphoma | – | Drug: Brentuximab-Vedotin associated with Bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with relapsed or refractory HL, after at least one first line of treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Minor patients
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab-Vedotin associated with BendamustinePatient having received at least one course of the association Brentuximab-Vedotin and Bendamustine | Drug | Patient with relapsed or refractory Hodgkin Lymphoma |
Primary outcome
Progression free survival (PFS) for the whole cohort
Time frame: 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
Measured from the time of treatment initiation to the date of event : progression or death
1 secondary outcome
Overal survival (OS) for the whole cohort
Time frame: From date of inclusion until the date of death from any cause assessed up to 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Hodgkin Lymphoma, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) for the whole cohort (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.