Hodgkin LymphomaHL_PR/R-BNCT06295211
Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
An observational study of Hodgkin Lymphoma, run by Federico II University.
Trial summary
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- observational
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 22 Feb 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
Who may be able to join
- patients age between 18 years and 60 years;
- histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment [after 2 cycles of ABVD] with interim FDG-PET/CT with Deauville scale score of 5 [primary refractory patients])
- treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively
- metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT)
- EGOG performance status 0-2 (or 3, if due to illness).
Who cannot join
- patients not fulfilling inclusion criteria
About this study
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
Read the detailed description
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
The regimen consisted of 3-day outpatient intravenous infusions of 1.8 mg/kg Bv on Day 1 of each 3-week cycle (as established by Younes and colleagues) sequentially combined with bendamustine (at least 24 hours after Bv, precisely on days 2 and 3 of the treatment cycle; as reported by Picardi et al) at a fixed dose of 120 mg/m2 per day.
All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell (PBSC) collection (performed with granulocyte colony-stimulating factor [G-CSF] and endoxan or plerixafor, if necessary) and proceeded to ASCT at any time beyond cycle 4.
The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment.
Prior to the first cycle of Bv-Bs, all patients underwent a clinical evaluation that included assessment of B symptoms, World Health Organization performance status, and measurement of palpable lesions. In particular, imaging procedures were conducted after the second and fourth cycles or prior to ASCT. The response was based on international criteria (Cheson et al, 2016). PET scans were considered positive or negative based on the Deauville 5-point scale criteria.
- Conditions
- Hodgkin Lymphoma
- Being tested
- observational
- Keywords
- Hodgkin lymphoma, primary refractory, bendamustine supercharge, brentuximab vedotin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
survival
Measured: 10 year period
Secondary outcomes (3)
Progression overall survival
survival
Measured: 10 year period
Response to treatment
Complete Metabolic Remission rate
Measured: at end of 4 cycles treatment (each cycle of 28 days)
Incidence of treatment emergent adverse events
side effect to regimen related to both Brentuximab and bendamustine
Measured: during 4 cycles of treatment (each cycle of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Sep 2013
- Primary completion1 Sep 2023
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Picardi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295211
- Sponsor's protocol ID
- FEDII_HL_PR/R-Bv-Bs
- Acronym
- HL_PR/R-B
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Picardi M, Della Pepa R, Giordano C, Pugliese N, Mortaruolo C, Trastulli F, Rascato MG, Cappuccio I, Raimondo M, Memoli M, Monteverde M, Mascolo M, Pane F. Brentuximab vedotin followed by bendamustine supercharge for refractory or relapsed Hodgkin lymphoma. Blood Adv. 2019 May 14;3(9):1546-1552. doi: 10.1182/bloodadvances.2019000123.
PubMed 31088808Cheson BD, Ansell S, Schwartz L, Gordon LI, Advani R, Jacene HA, Hoos A, Barrington SF, Armand P. Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy. Blood. 2016 Nov 24;128(21):2489-2496. doi: 10.1182/blood-2016-05-718528. Epub 2016 Aug 29.
PubMed 27574190
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
- ClinicalTrials.gov ID
- NCT06295211
- Acronym / sponsor ID
- HL_PR/R-B / FEDII_HL_PR/R-Bv-Bs
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin lymphoma, primary refractory, bendamustine supercharge, brentuximab vedotin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 6 Mar 2024 (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.
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
Detailed description
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
The regimen consisted of 3-day outpatient intravenous infusions of 1.8 mg/kg Bv on Day 1 of each 3-week cycle (as established by Younes and colleagues) sequentially combined with bendamustine (at least 24 hours after Bv, precisely on days 2 and 3 of the treatment cycle; as reported by Picardi et al) at a fixed dose of 120 mg/m2 per day.
All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell (PBSC) collection (performed with granulocyte colony-stimulating factor [G-CSF] and endoxan or plerixafor, if necessary) and proceeded to ASCT at any time beyond cycle 4.
The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment.
Prior to the first cycle of Bv-Bs, all patients underwent a clinical evaluation that included assessment of B symptoms, World Health Organization performance status, and measurement of palpable lesions. In particular, imaging procedures were conducted after the second and fourth cycles or prior to ASCT. The response was based on international criteria (Cheson et al, 2016). PET scans were considered positive or negative based on the Deauville 5-point scale criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
Key inclusion criteria (5 listed)
- patients age between 18 years and 60 years;
- histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment [after 2 cycles of ABVD] with interim FDG-PET/CT with Deauville scale score of 5 [primary refractory patients])
- treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively
- metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT)
- EGOG performance status 0-2 (or 3, if due to illness).
Key exclusion criteria (1 listed)
- patients not fulfilling inclusion criteria
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 |
|---|---|---|
| observationalobservational | Other | – |
Primary outcome
Overall survival
Time frame: 10 year period
survival
3 secondary outcomes
Progression overall survival
Time frame: 10 year period
Response to treatment
Time frame: at end of 4 cycles treatment (each cycle of 28 days)
Incidence of treatment emergent adverse events
Time frame: during 4 cycles of treatment (each cycle of 28 days)
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 6 Mar 2024.
- Results publication: PubMed 31088808Picardi M, Della Pepa R, Giordano C, Pugliese N, Mortaruolo C, Trastulli F, Rascato MG, Cappuccio I, Raimondo M, Memoli M, Monteverde M, Mascolo M, Pane F. Brentuximab vedotin followed by bendamustine supercharge for refractory or relapsed Hodgkin lymphoma. Blood Adv. 2019 May 14;3(9):1546-1552. doi: 10.1182/bloodadvances.2019000123.
- Results publication: PubMed 27574190Cheson BD, Ansell S, Schwartz L, Gordon LI, Advani R, Jacene HA, Hoos A, Barrington SF, Armand P. Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy. Blood. 2016 Nov 24;128(21):2489-2496. doi: 10.1182/blood-2016-05-718528. Epub 2016 Aug 29.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Federico II University.
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 5 inclusion and 1 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall survival (time frame: 10 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295211, which also lists 2 linked publications.
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 6 Mar 2024.