Using Brentuximab Vedotin to treat newly diagnosed Classical Hodgkin Lymphoma in young patients
Official title: A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
Run by Children's Cancer Group, China · NCT06563245 · Data updated 2026-11-12
This study is testing if a new treatment with Brentuximab vedotin can help young patients with newly diagnosed classical Hodgkin lymphoma feel better while reducing the need for chemotherapy and radiation.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 35 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Children's Cancer Group, China Research network |
| Drugs / interventions | Brentuximab, chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 25, 2024 |
| Main results expected | November 15, 2029 |
| Study ends | November 15, 2039 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT06563245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children, adolescents, and young adults aged 2 to 35 with newly diagnosed classical Hodgkin lymphoma.
✕Probably not a fit
Patients with nodular lymphocyte-predominant Hodgkin lymphoma or those with pre-existing immunodeficiencies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Brentuximab vedotin as part of a new treatment regimen for children, adolescents, and young adults with newly diagnosed classical Hodgkin lymphoma. The approach aims to replace certain chemotherapy agents to enhance early response rates and reduce the need for radiation therapy. Patients will be assessed using PET/CT scans to determine their response to treatment, with adjustments made for those who do not achieve complete metabolic remission. The goal is to maintain high event-free survival rates while minimizing long-term side effects.
Why it matters
Potential benefit: If successful, this treatment could significantly improve early response rates and reduce the need for radiation therapy in young patients with Hodgkin lymphoma.
How similar studies have gone: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this novel regimen.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Shanghai Children's Medical Center
Shanghai, China Recruiting
Study contacts
- Principal investigator: Yi Jin Gao, Md — Shanghai Children's Medical Center
- Study coordinator: Yi Jin Gao, Md
- Email: gaoyijin@scmc.com.cn
- Phone: 86-21-38087513
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.