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Classical Hodgkin LymphomaPhase 2/3NCT06563245

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment

A Phase 2/3 study testing Brentuximab Vedotin for Injection, response-adapted radiation and Doxorubicin in people with Classical Hodgkin Lymphoma and Child, run by Children's Cancer Group, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 35 years
Conditions the study is for
Classical Hodgkin Lymphoma, Child, Adolescent
What is being tested?
Brentuximab Vedotin for Injection, response-adapted radiation and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
25 Sep 2024to 15 Nov 2039
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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;

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

YI JIN GAO, MD contact

86-21-38087513

gaoyijin@scmc.com.cn

JIE ZHAO contact

zhaojie@scmc.com.cn

China1 site, 1 recruiting

  • Shanghai Children's Medical Center

    Shanghai

    Recruiting

Other trials in China

About this study

Official title: A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment

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.

Read 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 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.

Being tested
Brentuximab Vedotin for Injection, response-adapted radiation, Doxorubicin, Etoposide, Prednisone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab Vedotin for InjectionDrug

    1.8mg/kg/dose (MAX 180 mg)

  • response-adapted radiationRadiation

    For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.

  • DoxorubicinDrug

    25mg/m2/dose,

  • EtoposideDrug

    125 mg/m2/dose

  • PrednisoneDrug

    20 mg/m2, BID, orally

  • CyclophosphamideDrug

    600 mg/m2/dose

  • DacarbazineDrug

    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 InjectionDrug

    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.

  • BedamustineDrug

    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 groups in NCT06563245
Study groupRoleWhat they receive
Low risk groupExperimentalStage IA , no bulky Stage IIA, no bulky
Receives: Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide
Intermediate risk groupExperimentalStage 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
Receives: Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Dacarbazine; Drug: Tislelizumab Injection; Drug: Bedamustine
High risk groupExperimentalStage IIB Stage IIIB Stage IV
Receives: Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Dacarbazine; Drug: Tislelizumab Injection; Drug: Bedamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 years

  2. 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

    Measured: 5 years

  3. 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

    Measured: 5 years

  4. Overall survival rate for the entire group and each risk group

    the overall survival rate for all the patients enrolled

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start25 Sep 2024
  3. Primary completion15 Nov 2029 (estimated)
  4. Study completion15 Nov 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06563245
Sponsor's protocol ID
CCCG-HL-2024
Status last verified
Mar 2026
First submitted
18 Aug 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Monthly meeting within the group

Publications

  • Huang 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.

    PubMed 35546241

  • Bao 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.

    PubMed 23927803

  • Nie 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.

    PubMed 36319153

  • Castellino 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.

    PubMed 36322844

  • Metzger 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.

    PubMed 33826362

  • Vardhana 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.

    PubMed 30082490

  • Harker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118.

    PubMed 36564047

  • Friedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.

    PubMed 25311218

  • Kluge R, Kurch L, Georgi T, Metzger M. Current Role of FDG-PET in Pediatric Hodgkin's Lymphoma. Semin Nucl Med. 2017 May;47(3):242-257. doi: 10.1053/j.semnuclmed.2017.01.001. Epub 2017 Mar 6.

    PubMed 28417854

  • Mauz-Korholz C, Metzger ML, Kelly KM, Schwartz CL, Castellanos ME, Dieckmann K, Kluge R, Korholz D. Pediatric Hodgkin Lymphoma. J Clin Oncol. 2015 Sep 20;33(27):2975-85. doi: 10.1200/JCO.2014.59.4853. Epub 2015 Aug 24.

    PubMed 26304892

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Brentuximab Vedotin for Injection, response-adapted radiation and Doxorubicin in people with Classical Hodgkin Lymphoma and Child, run by Children's Cancer Group, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YI JIN GAO, MD (86-21-38087513, gaoyijin@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early complete metabolic response rate for the entire group (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06563245, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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