Clinical trial NCT06563245: Brentuximab Vedotin for Newly Diagnosed CHL in Chinese CAYA Based on PET/CT Assessment
Official title: A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Classical Hodgkin Lymphoma
Child
Adolescent
Young Adult
Metabolic Response
Survival
Treatment
Brentuximab Vedotin
PET Scan
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
Collaborators: name: Shanghai Children's Medical Center
name: Najing Children's Hospital
name: West China Second University Hospital
name: Qilu Hospital of Shandong University
name: Tianjin Medical University Cancer Institute and Hospital
name: Tongji Hospital
name: Xiangya Hospital of Central South University
name: The First Affiliated Hospital of Zhengzhou University
name: Second Affiliated Hospital of Anhui Medical University
name: Children's Hospital of Hebei Province
name: Children's Hospital of Henan Province
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2024-08-20
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Early complete metabolic response rate for the entire group
timeFrame: 5 years
measure: Late complete metabolic response rate in intermediate/high risk group
timeFrame: 5 years
measure: Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens
timeFrame: 5 years
measure: Overall survival rate for the entire group and each risk group
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
affiliation: Shanghai Children&#39;s Medical Center
name: YI JIN GAO, MD
role: PRINCIPAL_INVESTIGATOR
References:
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