Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06761911

BV 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • <18 years

Treatment and study plan

Brentuximab Vedotin (Bv)

Drug

1.2mg/kg/2w or 1.8mg/kg/3w

Other names: BV, Adcetris

Sintilimab

Drug

200mg/3w

Other names: TYVYT

Tislelizumab

Drug

200mg/3w

Other names: TEVIMBRA

Bendamustine

Drug

90mg/m2/3w

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Safety and tolerability of Brentuximab Vedotin

    Time frame: 1 year

    Adverse reactions after application of BV-containing regimen, especially hematologic toxicity

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Xiuhua Sun

Other

Registry information

Official study title

A Real-world Study of Brentuximab Vedotin Monotherapy and Combination Regimens in the Treatment of Relapsed/Refractory Hodgkin Lymphoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.