NCT06563245 Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
| NCT ID | NCT06563245 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Children's Cancer Group, China |
| Condition | Classical Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2029-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 96 participants in total. It began in 2024-09-25 with a primary completion date of 2029-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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; Exclusion Criteria: * 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
Contact & Investigator
YI JIN GAO, MD
PRINCIPAL INVESTIGATOR
Shanghai Children's Medical Center
Frequently Asked Questions
Who can join the NCT06563245 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 35 Years, studying Classical Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06563245 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06563245 currently recruiting?
Yes, NCT06563245 is actively recruiting participants. Contact the research team at gaoyijin@scmc.com.cn for enrollment information.
Where is the NCT06563245 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06563245 clinical trial?
NCT06563245 is sponsored by Children's Cancer Group, China. The principal investigator is YI JIN GAO, MD at Shanghai Children's Medical Center. The trial plans to enroll 96 participants.