Trial Title:
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
NCT ID:
NCT06563245
Condition:
Classical Hodgkin Lymphoma
Child
Adolescent
Young Adult
Metabolic Response
Survival
Treatment
Brentuximab Vedotin
PET Scan
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Prednisone
Cyclophosphamide
Dacarbazine
Doxorubicin
Etoposide
Tislelizumab
Brentuximab Vedotin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Brentuximab Vedotin for Injection
Description:
1.8mg/kg/dose (MAX 180 mg)
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Radiation
Intervention name:
response-adapted radiation
Description:
For patients who did not achieve complete metabolic response at early response assessment
based on PET/CT result.
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
25mg/m2/dose,
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Etoposide
Description:
125 mg/m2/dose
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Prednisone
Description:
20 mg/m2, BID, orally
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
600 mg/m2/dose
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Dacarbazine
Description:
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.
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Intervention type:
Drug
Intervention name:
Tislelizumab Injection
Description:
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.
Arm group label:
High risk group
Arm group label:
Intermediate risk group
Intervention type:
Drug
Intervention name:
Bedamustine
Description:
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.
Arm group label:
High risk group
Arm group label:
Intermediate risk group
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. 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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
2 Years
Maximum age:
35 Years
Healthy volunteers:
No
Start date:
September 25, 2024
Completion date:
November 15, 2039
Lead sponsor:
Agency:
Children's Cancer Group, China
Agency class:
Other
Collaborator:
Agency:
Shanghai Children's Medical Center
Agency class:
Other
Collaborator:
Agency:
Najing Children's Hospital
Agency class:
Other
Collaborator:
Agency:
West China Second University Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Children's Hospital of Hebei Province
Agency class:
Other
Collaborator:
Agency:
Children's Hospital of Henan Province
Agency class:
Other
Collaborator:
Agency:
Sun Yat-Sen Memorial Hospital Zhongshan University
Agency class:
Other
Source:
Children's Cancer Group, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06563245
