RecruitingPhase 2Phase 3NCT06563245

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment

A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment

Sponsor

Children's Cancer Group, China

Enrollment

96 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment Survival Classical Hodgkin Lymphoma Adolescent Child Young Adult Metabolic Response Brentuximab Vedotin PET Scan

Summary

Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

Eligibility

Min Age: 2 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether brentuximab vedotin — a targeted antibody-drug — can be incorporated into treatment for children, adolescents, and young adults (up to age 35) newly diagnosed with classical Hodgkin lymphoma in China, using PET/CT scans to guide how intensively the treatment is given. **You may be eligible if...** - You are aged 2 to under 35 years with a newly diagnosed classical Hodgkin lymphoma confirmed by at least two specialist pathology centers - Your organ function is adequate - You or your parent/guardian can provide written consent **You may NOT be eligible if...** - You have nodular lymphocyte-predominant Hodgkin lymphoma (a different subtype) - You have a prior immune deficiency, have had an organ transplant, or are known to be HIV-positive - You are pregnant or breastfeeding - You have received systemic steroids within the past 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab Vedotin for Injection

1.8mg/kg/dose (MAX 180 mg)

RADIATIONresponse-adapted radiation

For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.

DRUGDoxorubicin

25mg/m2/dose,

DRUGEtoposide

125 mg/m2/dose

DRUGPrednisone

20 mg/m2, BID, orally

DRUGCyclophosphamide

600 mg/m2/dose

DRUGDacarbazine

250 mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at early assessment based on PET/CT results.

DRUGTislelizumab Injection

3mg/kg/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.

DRUGBedamustine

180mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.