Brentuximab Vedotin for Injectionresponse-adapted radiationDoxorubicinEtoposidePrednisoneCyclophosphamideDacarbazineTislelizumab InjectionBedamustine
Brentuximab Vedotin for Injection: 1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation: For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin: 25mg/m2/dose,
Etoposide: 125 mg/m2/dose
Prednisone: 20 mg/m2, BID, orally
Cyclophosphamide: 600 mg/m2/dose
Dacarbazine: 250 mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at early assessment based on PET/CT results.
Tislelizumab Injection: 3mg/kg/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.
Bedamustine: 180mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.
Study 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
Sex
ALL
Min age
2 Years
Max age
35 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Early complete metabolic response rate for the entire group — 5 years Early complete metabolic response rate after 2 cycle of Bv-AEPC based on PET/CT result for the entire group
Late complete metabolic response rate in intermediate/high risk group — 5 years Late complete metabolic response rate based on PET/CT results for patients who did not achieve early complete metabolic response after 2 or 3 cycles of Bv-Dac-AEPC
Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens — 5 years Complete metabolic response rate based on PET/CT results for patients who receive a modified Check Mate 744 regimen
Overall survival rate for the entire group and each risk group — 5 years the overall survival rate for all the patients enrolled
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.