Using Brentuximab Vedotin to treat newly diagnosed Classical Hodgkin Lymphoma in young patients
A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
PHASE2; PHASE3 · Children's Cancer Group, China · NCT06563245
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 |
| Enrollment | 96 (estimated) |
| Ages | 2 Years to 35 Years |
| Sex | All |
| Sponsor | Children's Cancer Group, China (network) |
| Drugs / interventions | Brentuximab, chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06563245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children, adolescents, and young adults aged 2 to 35 with newly diagnosed classical Hodgkin lymphoma.
Not a fit: Patients with nodular lymphocyte-predominant Hodgkin lymphoma or those with pre-existing immunodeficiencies will not benefit from this study.
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 performed: Previous studies have shown promising results with similar treatment approaches, indicating potential for success in this novel regimen.
Eligibility criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Classical Hodgkin Lymphoma, Child, Adolescent, Young Adult, Metabolic Response, Survival, Treatment, Brentuximab Vedotin