Clinical trial · Interventional
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescent | — | UNRESOLVED | — |
| Brentuximab Vedotin | — | UNRESOLVED | — |
| Child | — | UNRESOLVED | — |
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Metabolic Response | — | UNRESOLVED | — |
| PET Scan | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
| Treatment | — | UNRESOLVED | — |
| Young Adult | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bedamustine | Drug | — | UNRESOLVED |
| Brentuximab Vedotin for Injection | Drug | Brentuximab Vedotin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| response-adapted radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low risk group
- description
- Stage IA , no bulky Stage IIA, no bulky
- interventionNames
- Drug: Brentuximab Vedotin for Injection
- Radiation: response-adapted radiation
- Drug: Doxorubicin
- Drug: Etoposide
- Drug: Prednisone
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Intermediate risk group
- description
- 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
- interventionNames
- Drug: Brentuximab Vedotin for Injection
- Radiation: response-adapted radiation
- Drug: Doxorubicin
- Drug: Etoposide
- Drug: Prednisone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDHuang J, Pang WS, Lok V, Zhang L, Lucero-Prisno DE 3rd, Xu W, Zheng ZJ, Elcarte E, Withers M, Wong MCS; NCD Global Health Research Group, Association of Pacific Rim Universities (APRU). Incidence, mortality, risk factors, and trends for Hodgkin lymphoma: a global data analysis. J Hematol Oncol. 2022 May 11;15(1):57. doi: 10.1186/s13045-022-01281-9. PMID 35546241
- BACKGROUNDBao PP, Li K, Wu CX, Huang ZZ, Wang CF, Xiang YM, Peng P, Gong YM, Xiao XM, Zheng Y. [Recent incidences and trends of childhood malignant solid tumors in Shanghai, 2002-2010]. Zhonghua Er Ke Za Zhi. 2013 Apr;51(4):288-94. Chinese. PMID 23927803
- BACKGROUNDNie DM, Yuan Q, Yu Y, Wu CJ, Guo X, Zhang AJ, Wang J, Xiao LY, Weng KZ, Fang YJ, Ju XL, Gao J, Xu ZJ, Yang LC, Liu AG, Gao YJ. [A multicenter study on childhood Hodgkin lymphoma treated with HL-2013 regimen in China]. Zhonghua Er Ke Za Zhi. 2022 Nov 2;60(11):1172-1177. doi: 10.3760/cma.j.cn112140-20220312-00196. Chinese. PMID 36319153
- BACKGROUNDCastellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, Cho S, Wu Y, Punnett A, Dave H, Henderson TO, Hoppe BS, Charpentier AM, Keller FG, Kelly KM. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022 Nov 3;387(18):1649-1660. doi: 10.1056/NEJMoa2206660. PMID 36322844
- BACKGROUNDMetzger ML, Link MP, Billett AL, Flerlage J, Lucas JT Jr, Mandrell BN, Ehrhardt MJ, Bhakta N, Yock TI, Friedmann AM, de Alarcon P, Luna-Fineman S, Larsen E, Kaste SC, Shulkin B, Lu Z, Li C, Hiniker SM, Donaldson SS, Hudson MM, Krasin MJ. Excellent Outcome for Pediatric Patients With High-Risk Hodgkin Lymphoma Treated With Brentuximab Vedotin and Risk-Adapted Residual Node Radiation. J Clin Oncol. 2021 Jul 10;39(20):2276-2283. doi: 10.1200/JCO.20.03286. Epub 2021 Apr 7. PMID 33826362
- BACKGROUNDVardhana S, Cicero K, Velez MJ, Moskowitz CH. Strategies for Recognizing and Managing Immune-Mediated Adverse Events in the Treatment of Hodgkin Lymphoma with Checkpoint Inhibitors. Oncologist. 2019 Jan;24(1):86-95. doi: 10.1634/theoncologist.2018-0045. Epub 2018 Aug 6.