Status:
RECRUITING
Brentuximab Vedotin for Newly Diagnosed CHL in Chinese CAYA Based on PET/CT Assessment
Lead Sponsor:
Children's Cancer Group, China
Collaborating Sponsors:
Shanghai Children's Medical Center
Najing Children's Hospital
Conditions:
Classical Hodgkin Lymphoma
Child
Eligibility:
All Genders
2-35 years
Phase:
PHASE2
PHASE3
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 the...
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2039
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06563245
Start Date
September 25 2024
End Date
November 15 2039
Last Update
February 13 2025
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, China