A Phase 2/3 interventional study of Brentuximab Vedotin for Injection and response-adapted radiation in Classical Hodgkin Lymphoma, Child and Adolescent, sponsored by Children's Cancer Group, China. Recruiting at 1 site in China. Open to participants aged 2 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Children's Cancer Group, China · Phase 2/3, Interventional, and Treatment
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.
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. Bv is currently the most widely used "new drug" in childhood cHL.
For patients in the intermediate/high-risk group who did not achieve metabolic complete remission rate (CMR) at the early assessment based on PET/CT results, an intensive regimen of Bv-Dac-APC (Bv-APC plus dacarbazine) was applied for 2 or 3 courses to further improve event-free survival without increasing long-term reproductive toxicity.
For patients in the intermediate/high-risk group who did not achieve CMR after the Bv-Dac-AEPC regimen, a modified Check Mate 744 regimen (PD-1 monoclonal antibody, Bv,+/-bedamostine, autologous stem cell transplantation/radiotherapy) was applied to improve the CMR of patients before irradiation, hoping to reduce the primary treatment failure rate to almost zero.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's planned enrollment of 96 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Children's Cancer Group, China is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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The human immunodeficiency virus, which weakens the immune system.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stage IA , no bulky Stage IIA, no bulky
Drug: Brentuximab Vedotin for Injection · Radiation: response-adapted radiation · Drug: Doxorubicin · Drug: Etoposide · Drug: Prednisone · Drug: Cyclophosphamide
Stage IA, with bulky Stage IIA, with bulky Stage IB, with/without bulky Stage IAE, with/without bulky Stage IIAE, with/without bulky Stage IIIA, with/without bulky
Drug: Brentuximab Vedotin for Injection · Radiation: response-adapted radiation · Drug: Doxorubicin · Drug: Etoposide · Drug: Prednisone · Drug: Cyclophosphamide · Drug: Dacarbazine · Drug: Tislelizumab Injection · Drug: Bedamustine
Stage IIB Stage IIIB Stage IV
Drug: Brentuximab Vedotin for Injection · Radiation: response-adapted radiation · Drug: Doxorubicin · Drug: Etoposide · Drug: Prednisone · Drug: Cyclophosphamide · Drug: Dacarbazine · Drug: Tislelizumab Injection · Drug: Bedamustine
1.8mg/kg/dose (MAX 180 mg)
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
25mg/m2/dose,
125 mg/m2/dose
20 mg/m2, BID, orally
600 mg/m2/dose
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.
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.
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.
Early complete metabolic response rate for the entire group
Early complete metabolic response rate after 2 cycle of Bv-AEPC based on PET/CT result for the entire group
Time frame: 5 years
Late complete metabolic response rate in intermediate/high risk group
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
Time frame: 5 years
Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens
Complete metabolic response rate based on PET/CT results for patients who receive a modified Check Mate 744 regimen
Time frame: 5 years
Overall survival rate for the entire group and each risk group
the overall survival rate for all the patients enrolled
Time frame: 5 years
Plan to share: Yes — Monthly meeting within the group
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: From October 15 2024 to the end of the study.
Access criteria: After IRB approval is received.
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Studies of the drug tested here: Brentuximab Vedotin
Children's Cancer Group, China