Brentuximab Vedotin for Newly Diagnosed CHL in Chinese CAYA Based on PET/CT Assessment
NCT ID: NCT06563245
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
96 participants
INTERVENTIONAL
2024-09-25
2039-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Low risk group
Stage IA , no bulky Stage IIA, no bulky
Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
25mg/m2/dose,
Etoposide
125 mg/m2/dose
Prednisone
20 mg/m2, BID, orally
Cyclophosphamide
600 mg/m2/dose
Intermediate risk group
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
Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
25mg/m2/dose,
Etoposide
125 mg/m2/dose
Prednisone
20 mg/m2, BID, orally
Cyclophosphamide
600 mg/m2/dose
Dacarbazine
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.
Tislelizumab Injection
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.
Bedamustine
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
Stage IIB Stage IIIB Stage IV
Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
25mg/m2/dose,
Etoposide
125 mg/m2/dose
Prednisone
20 mg/m2, BID, orally
Cyclophosphamide
600 mg/m2/dose
Dacarbazine
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.
Tislelizumab Injection
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.
Bedamustine
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.
Interventions
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Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
25mg/m2/dose,
Etoposide
125 mg/m2/dose
Prednisone
20 mg/m2, BID, orally
Cyclophosphamide
600 mg/m2/dose
Dacarbazine
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.
Tislelizumab Injection
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.
Bedamustine
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
35 Years
ALL
No
Sponsors
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Shanghai Children's Medical Center
OTHER
Najing Children's Hospital
UNKNOWN
West China Second University Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Tongji Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Second Affiliated Hospital of Anhui Medical University
UNKNOWN
Children's Hospital of Hebei Province
OTHER
Children's Hospital of Henan Province
UNKNOWN
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Children's Cancer Group, China
NETWORK
Responsible Party
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Principal Investigators
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YI JIN GAO, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center
Locations
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Shanghai Children's Medical Center
Shanghai, , China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CCCG-HL-2024
Identifier Type: -
Identifier Source: org_study_id
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