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

Children's Cancer Group, China

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Survival; Treatment; Young Adult; Child; Metabolic Response; Adolescent; Classical Hodgkin Lymphoma; PET Scan; Brentuximab Vedotin

Treatments: Drug: Tislelizumab Injection; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Dacarbazine; Radiation: response-adapted radiation; Drug: Etoposide; Drug: Bedamustine; Drug: Prednisone; Drug: Brentuximab Vedotin for Injection

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06563245

CCCG-HL-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 2 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Low risk group

Experimental group

Description:

Stage IA , no bulky Stage IIA, no bulky

Treatment:

Drug: Brentuximab Vedotin for Injection

Drug: Prednisone

Drug: Etoposide

Radiation: response-adapted radiation

Drug: Doxorubicin

Drug: Cyclophosphamide

Intermediate risk group

Experimental group

Description:

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

Treatment:

Drug: Brentuximab Vedotin for Injection

Drug: Prednisone

Drug: Bedamustine

Drug: Etoposide

Radiation: response-adapted radiation

Drug: Dacarbazine

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Tislelizumab Injection

High risk group

Experimental group

Description:

Stage IIB Stage IIIB Stage IV

Treatment:

Drug: Brentuximab Vedotin for Injection

Drug: Prednisone

Drug: Bedamustine

Drug: Etoposide

Radiation: response-adapted radiation

Drug: Dacarbazine

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Tislelizumab Injection