Hodgkin Lymphoma (Category)Phase 4NCT06761911
BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma
A Phase 4 study testing Brentuximab Vedotin (Bv), Sintilimab and Tislelizumab in people with Hodgkin Lymphoma (Category), run by Xiuhua Sun.
Trial summary
The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma (Category)
- What is being tested?
- Brentuximab Vedotin (Bv), Sintilimab and Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Histologically, classical hodgkin lymphoma（cHL） was diagnosed and relapsed or refractory.
- Patients were treated with BV-containing regimen at least once
- Presence of tumor (measurable or nonmeasurable).
- Signature of the form consent for participation in the study.
Who cannot join
- <18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-world Study of Brentuximab Vedotin Monotherapy and Combination Regimens in the Treatment of Relapsed/Refractory Hodgkin Lymphoma
The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. The main questions it aims to answer are:
To evaluate the efficacy and toxicity of BV-containing regimen in relapsed/refractory CHL patients in China, and to provide reference for the rational and safe use of BV in clinical practice.
Read the detailed description
Part I: Retrospective study The clinical data of 50 cases of relapsed/refractory CHL treated with BV in multiple centers in the past 3 years were collected. Statistical methods were used to compare the efficacy and safety between groups and subgroups.
Part II: Prospective study The study was conducted in about 20 centers in China. The preliminary plan was to select a large grade A tertiary hospital with lymphoma specialty center as a sub-center, and an investigator meeting was held to further discuss the choice of drug administration and combination therapy for patients. It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. For the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. PET-CT is recommended for efficacy evaluation, and enhanced CT can also be used for patients with poor economic conditions.
- Conditions
- Hodgkin Lymphoma (Category)
- Being tested
- Brentuximab Vedotin (Bv), Sintilimab, Tislelizumab, Bendamustine
- Keywords
- Brentuximab Vedotin, Hodgkin lymphoma, refractory recurrence, real world, china
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin (Bv)Drug
Also called BV, Adcetris
1.2mg/kg/2w or 1.8mg/kg/3w
SintilimabDrug
Also called TYVYT
200mg/3w
TislelizumabDrug
Also called TEVIMBRA
200mg/3w
BendamustineDrug
90mg/m2/3w
| Study group | Role | What they receive |
|---|---|---|
| BV monotherapy group | Active comparator | It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. Receives: Drug: Brentuximab Vedotin (Bv) |
| BV combined treatment group | Active comparator | For the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. Receives: Drug: Brentuximab Vedotin (Bv); Drug: Sintilimab; Drug: Tislelizumab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary Overall Response Rate (ORR)
Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy.
Measured: Up to 16 cycles (each cycle is 21 days)
Progression-free survival (PFS)
Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date.
Measured: From time of study enrollment until first documentation of progressive disease or death from any cause, assessed up to 3 years
Secondary outcomes (1)
Safety and tolerability of Brentuximab Vedotin
Adverse reactions after application of BV-containing regimen, especially hematologic toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion17 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma (Category)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuhua Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuhua Sun, Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761911
- Sponsor's protocol ID
- DalianMU
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 7 Jan 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Brentuximab Vedotin Monotherapy and Combination Regimens in the Treatment of Relapsed/Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06761911
- Acronym / sponsor ID
- DalianMU
- Conditions
- Hodgkin Lymphoma (Category)
- Keywords
- Brentuximab Vedotin, Hodgkin lymphoma, refractory recurrence, real world, china
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiuhua SunUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 Jan 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.
The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. The main questions it aims to answer are:
To evaluate the efficacy and toxicity of BV-containing regimen in relapsed/refractory CHL patients in China, and to provide reference for the rational and safe use of BV in clinical practice.
Detailed description
Part I: Retrospective study The clinical data of 50 cases of relapsed/refractory CHL treated with BV in multiple centers in the past 3 years were collected. Statistical methods were used to compare the efficacy and safety between groups and subgroups.
Part II: Prospective study The study was conducted in about 20 centers in China. The preliminary plan was to select a large grade A tertiary hospital with lymphoma specialty center as a sub-center, and an investigator meeting was held to further discuss the choice of drug administration and combination therapy for patients. It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. For the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. PET-CT is recommended for efficacy evaluation, and enhanced CT can also be used for patients with poor economic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BV monotherapy group | Active comparator | Drug: Brentuximab Vedotin (Bv)It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. |
| BV combined treatment group | Active comparator | Drug: Brentuximab Vedotin (Bv), Drug: Sintilimab, Drug: Tislelizumab, Drug: BendamustineFor the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically, classical hodgkin lymphoma（cHL） was diagnosed and relapsed or refractory.
- Patients were treated with BV-containing regimen at least once
- Presence of tumor (measurable or nonmeasurable).
- Signature of the form consent for participation in the study.
Key exclusion criteria (1 listed)
- <18 years
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 (Bv)Also: BV, Adcetris1.2mg/kg/2w or 1.8mg/kg/3w | Drug | BV combined treatment group, BV monotherapy group |
| SintilimabAlso: TYVYT200mg/3w | Drug | BV combined treatment group |
| TislelizumabAlso: TEVIMBRA200mg/3w | Drug | BV combined treatment group |
| Bendamustine90mg/m2/3w | Drug | BV combined treatment group |
Primary outcome
Preliminary Overall Response Rate (ORR)
Time frame: Up to 16 cycles (each cycle is 21 days)
Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy.
Progression-free survival (PFS)
Time frame: From time of study enrollment until first documentation of progressive disease or death from any cause, assessed up to 3 years
Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date.
1 secondary outcome
Safety and tolerability of Brentuximab Vedotin
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brentuximab Vedotin (Bv), Sintilimab and Tislelizumab in people with Hodgkin Lymphoma (Category), run by Xiuhua Sun.
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 4 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: opening soon, as of the sponsor's last update on 7 Jan 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XIUHUA SUN (86-0411-84671291, 3038668@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Overall Response Rate (ORR) (time frame: Up to 16 cycles (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 7 Jan 2025.