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NCT Number: NCT06563245

Brentuximab Vedotin for Newly Diagnosed cHL 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.

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Key information

Age range

2 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shanghai Children's Medical Center

Shanghai, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin for Injection

Drug

1.8mg/kg/dose (MAX 180 mg)

response-adapted radiation

Radiation

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

Doxorubicin

Drug

25mg/m2/dose,

etoposide

Drug

125 mg/m2/dose

Prednisone

Drug

20 mg/m2, BID, orally

Cyclophosphamide

Drug

600 mg/m2/dose

Dacarbazine

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Early complete metabolic response rate for the entire group

    Time frame: 5 years

    Early complete metabolic response rate after 2 cycle of Bv-AEPC based on PET/CT result for the entire group

  2. Late complete metabolic response rate in intermediate/high risk group

    Time frame: 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

  3. Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens

    Time frame: 5 years

    Complete metabolic response rate based on PET/CT results for patients who receive a modified Check Mate 744 regimen

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

    Time frame: 5 years

    the overall survival rate for all the patients enrolled

Study contacts

Contact information is provided by the study sponsor or research team.

JIE ZHAO

CONTACT

[email protected]

YI JIN GAO, MD

CONTACT

[email protected]

86-21-38087513

Sponsors and collaborators

Lead sponsor

Children's Cancer Group, China

Network

Collaborators

  • Children's Hospital of Hebei Province
  • Children's Hospital of Henan Province
  • Najing Children's Hospital
  • Qilu Hospital of Shandong University
  • Shanghai Children's Medical Center
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Zhengzhou University
  • The Second Hospital of Anhui Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • Tongji Hospital
  • West China Second University Hospital
  • Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2039
First posted
Aug 20, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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