Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
Recruiting now · Phase 2/Phase 3
Conditions studied: Classical Hodgkin Lymphoma, Child, Adolescent, Young Adult, Metabolic Response, Survival, Treatment, Brentuximab Vedotin, PET Scan
In brief
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.
Key facts
- Study ID
- NCT06563245
- Run by
- Children's Cancer Group, China
- People needed
- 96
- Starts
- 2024-09-25
- Expected to finish
- 2039-11-15
- Last updated by the study team
- 2026-03-19
Who can join
Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages >=2\~<35 years at the time of enrollment;
- Patients with newly diagnosed, pathologically confirmed classical Hodgkin lymphoma (HL) by at least 2 tertiary referral centers for pathology;
- Adequate organ function;
- Patients and/or their parents or legal guardians sign a written informed consent;
You may not qualify if…
- Patients with nodular lymphocyte-predominant HL;
- Patients with an immunodeficiency that existed prior to diagnosis; such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible;Patients known to be positive for HIV are not eligible.
- Patients who are pregnant; Lactating females who plan to breastfeed.
- Patients who received systemic corticosteroids within 28 days of enrollment on this protocol
Where it is running
- Shanghai Children's Medical Center — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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