A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
| Registry | NCT06563245 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 96 (Estimated) |
| Sponsor | Children's Cancer Group, China (Network); collaborators: Shanghai Children's Medical Center, Nanjing Children's Hospital, West China Second University Hospital, Qilu Hospital of Shandong University, Tianjin Medical University Cancer Institute and Hospital, Tongji Hospital, Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Anhui Medical University, Children's Hospital of Hebei Province, Children's Hospital of Henan Province, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Conditions | Classical Hodgkin Lymphoma, Child, Adolescent, Young Adult, Metabolic Response, Survival, Treatment, Brentuximab Vedotin, PET Scan |
| Interventions | Brentuximab Vedotin for Injection, response-adapted radiation, Doxorubicin, Etoposide, Prednisone, Cyclophosphamide, Dacarbazine, Tislelizumab Injection, Bedamustine (Drug, radiation) |
| Dates | start 2024-09-25, primary completion 2029-11-15 (estimated), completion 2039-11-15 (estimated), first posted 2024-08-20, last updated 2026-03-19 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Classical Hodgkin Lymphoma All trials for Child All trials of Brentuximab Vedotin for Injection All trials of response-adapted radiation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Low risk group | Experimental | Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide | Stage IA , no bulky Stage IIA, no bulky |
| Intermediate risk group | Experimental | Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Dacarbazine; Drug: Tislelizumab Injection; Drug: Bedamustine | 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 |
| High risk group | Experimental | Drug: Brentuximab Vedotin for Injection; Radiation: response-adapted radiation; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Dacarbazine; Drug: Tislelizumab Injection; Drug: Bedamustine | Stage IIB Stage IIIB Stage IV |
Sex: All, ages: 2 Years to 35 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Children's Medical Center | Shanghai | China | Recruiting |