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

March 17, 2026 updated by: Children's Cancer Group, China

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low risk group
Stage IA , no bulky Stage IIA, no bulky
Drug: Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
Radiation: response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Drug: Doxorubicin
25mg/m2/dose,
Drug: Etoposide
125 mg/m2/dose
Drug: Prednisone
20 mg/m2, BID, orally
Drug: Cyclophosphamide
600 mg/m2/dose
Experimental: Intermediate risk group
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
1.8mg/kg/dose (MAX 180 mg)
Radiation: response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Drug: Doxorubicin
25mg/m2/dose,
Drug: Etoposide
125 mg/m2/dose
Drug: Prednisone
20 mg/m2, BID, orally
Drug: Cyclophosphamide
600 mg/m2/dose
Drug: 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.
Drug: 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.
Drug: 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.
Experimental: High risk group
Stage IIB Stage IIIB Stage IV
Drug: Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
Radiation: response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Drug: Doxorubicin
25mg/m2/dose,
Drug: Etoposide
125 mg/m2/dose
Drug: Prednisone
20 mg/m2, BID, orally
Drug: Cyclophosphamide
600 mg/m2/dose
Drug: 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.
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years
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
5 years
Overall survival rate for the entire group and each risk group
Time Frame: 5 years
the overall survival rate for all the patients enrolled
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Collaborators

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

Investigators

  • Principal Investigator: YI JIN GAO, MD, Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

November 15, 2029

Study Completion (Estimated)

November 15, 2039

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCG-HL-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Monthly meeting within the group

IPD Sharing Time Frame

From October 15 2024 to the end of the study.

IPD Sharing Access Criteria

After IRB approval is received.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent

Clinical Trials on Brentuximab Vedotin for Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe