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

NCT06563245 | Recruiting Phase 2 DMC

• 1 other identifier: CCCG-HL-2024
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Early complete metabolic response rate for the entire group

  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

  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

  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

  the overall survival rate for all the patients enrolled

  5 years

Study Arms (3)

Low risk group

EXPERIMENTAL

Stage IA , no bulky Stage IIA, no bulky

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

Intermediate risk group

EXPERIMENTAL

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

High risk group

EXPERIMENTAL

Stage IIB Stage IIIB Stage IV

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

Interventions

Brentuximab Vedotin for Injection DRUG

1.8mg/kg/dose (MAX 180 mg)

High risk group; Intermediate risk group; Low risk group

response-adapted radiation RADIATION

For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.

High risk group; Intermediate risk group; Low risk group

Doxorubicin DRUG

25mg/m2/dose,

High risk group; Intermediate risk group; Low risk group

Etoposide DRUG

125 mg/m2/dose

High risk group; Intermediate risk group; Low risk group

Prednisone DRUG

20 mg/m2, BID, orally

High risk group; Intermediate risk group; Low risk group

Cyclophosphamide DRUG

600 mg/m2/dose

High risk group; Intermediate risk group; Low risk group

Dacarbazine DRUG

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.

High risk group; Intermediate risk group

Tislelizumab Injection DRUG

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.

High risk group; Intermediate risk group

Bedamustine DRUG

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.

High risk group; Intermediate risk group

Eligibility Criteria

• Age: 2 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

RECRUITING

Related Publications (10)

• Huang J, Pang WS, Lok V, Zhang L, Lucero-Prisno DE 3rd, Xu W, Zheng ZJ, Elcarte E, Withers M, Wong MCS; NCD Global Health Research Group, Association of Pacific Rim Universities (APRU). Incidence, mortality, risk factors, and trends for Hodgkin lymphoma: a global data analysis. J Hematol Oncol. 2022 May 11;15(1):57. doi: 10.1186/s13045-022-01281-9.

  PMID: 35546241 BACKGROUND

• Bao PP, Li K, Wu CX, Huang ZZ, Wang CF, Xiang YM, Peng P, Gong YM, Xiao XM, Zheng Y. [Recent incidences and trends of childhood malignant solid tumors in Shanghai, 2002-2010]. Zhonghua Er Ke Za Zhi. 2013 Apr;51(4):288-94. Chinese.

  PMID: 23927803 BACKGROUND

• Nie DM, Yuan Q, Yu Y, Wu CJ, Guo X, Zhang AJ, Wang J, Xiao LY, Weng KZ, Fang YJ, Ju XL, Gao J, Xu ZJ, Yang LC, Liu AG, Gao YJ. [A multicenter study on childhood Hodgkin lymphoma treated with HL-2013 regimen in China]. Zhonghua Er Ke Za Zhi. 2022 Nov 2;60(11):1172-1177. doi: 10.3760/cma.j.cn112140-20220312-00196. Chinese.

  PMID: 36319153 BACKGROUND

• Castellino SM, Pei Q, Parsons SK, Hodgson D, McCarten K, Horton T, Cho S, Wu Y, Punnett A, Dave H, Henderson TO, Hoppe BS, Charpentier AM, Keller FG, Kelly KM. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022 Nov 3;387(18):1649-1660. doi: 10.1056/NEJMoa2206660.

  PMID: 36322844 BACKGROUND

• Metzger ML, Link MP, Billett AL, Flerlage J, Lucas JT Jr, Mandrell BN, Ehrhardt MJ, Bhakta N, Yock TI, Friedmann AM, de Alarcon P, Luna-Fineman S, Larsen E, Kaste SC, Shulkin B, Lu Z, Li C, Hiniker SM, Donaldson SS, Hudson MM, Krasin MJ. Excellent Outcome for Pediatric Patients With High-Risk Hodgkin Lymphoma Treated With Brentuximab Vedotin and Risk-Adapted Residual Node Radiation. J Clin Oncol. 2021 Jul 10;39(20):2276-2283. doi: 10.1200/JCO.20.03286. Epub 2021 Apr 7.

  PMID: 33826362 BACKGROUND

• Vardhana S, Cicero K, Velez MJ, Moskowitz CH. Strategies for Recognizing and Managing Immune-Mediated Adverse Events in the Treatment of Hodgkin Lymphoma with Checkpoint Inhibitors. Oncologist. 2019 Jan;24(1):86-95. doi: 10.1634/theoncologist.2018-0045. Epub 2018 Aug 6.

  PMID: 30082490 BACKGROUND

• Harker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118.

  PMID: 36564047 BACKGROUND

• Friedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.

  PMID: 25311218 BACKGROUND

• Kluge R, Kurch L, Georgi T, Metzger M. Current Role of FDG-PET in Pediatric Hodgkin's Lymphoma. Semin Nucl Med. 2017 May;47(3):242-257. doi: 10.1053/j.semnuclmed.2017.01.001. Epub 2017 Mar 6.

  PMID: 28417854 BACKGROUND

• Mauz-Korholz C, Metzger ML, Kelly KM, Schwartz CL, Castellanos ME, Dieckmann K, Kluge R, Korholz D. Pediatric Hodgkin Lymphoma. J Clin Oncol. 2015 Sep 20;33(27):2975-85. doi: 10.1200/JCO.2014.59.4853. Epub 2015 Aug 24.

  PMID: 26304892 BACKGROUND

MeSH Terms

Interventions

Brentuximab Vedotin; Injections; Doxorubicin; Etoposide; Prednisone; Cyclophosphamide; Dacarbazine; tislelizumab

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• YI JIN GAO, MD

  Shanghai Children&#39;s Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YI JIN GAO, MD

CONTACT

86-21-38087513; gaoyijin@scmc.com.cn

JIE ZHAO

CONTACT

zhaojie@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): November 15, 2029
• Study Completion (Estimated): November 15, 2039
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From October 15 2024 to the end of the study.
• Access Criteria: After IRB approval is received.

Locations

CN (1)