Brentuximab Vedotin (Bv)
Drug1.2mg/kg/2w or 1.8mg/kg/3w
Other names: BV, Adcetris
NCT Number: NCT06761911
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.2mg/kg/2w or 1.8mg/kg/3w
Other names: BV, Adcetris
200mg/3w
Other names: TYVYT
200mg/3w
Other names: TEVIMBRA
90mg/m2/3w
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.
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.
Time frame: 1 year
Adverse reactions after application of BV-containing regimen, especially hematologic toxicity
Contact information is provided by the study sponsor or research team.
Xiuhua Sun
Other
A Real-world Study of Brentuximab Vedotin Monotherapy and Combination Regimens in the Treatment of Relapsed/Refractory Hodgkin Lymphoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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