Status:
ENROLLING_BY_INVITATION
BV-AVD-R Treatment Children Hodgkin's Lymphoma
Lead Sponsor:
Beijing Children's Hospital
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to use modified Brentuximab Vedotin+doxorubicin+vinblastine+dacarbazine+Rituximab(BV-AVD-R) regimen in Chinese Classical Hodgkin's Lymphoma(HL) children. The main qu...
Detailed Description
This study is a prospective study with period from October 2022 to December 2024, and planned to enroll 44 children with newly diagnosed intermediate- and high-risk classical HL. All patients will und...
Eligibility Criteria
Inclusion
- Age ≤ 18 years old, regardless of gender;
- According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive;
- Newly diagnosed classic Hodgkin's lymphoma: all stages
- The main organs function normally and meet the following definitions:
- Blood routine examination: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 75 x 109/L, hemoglobin count ≥ 80 g/dL; Liver and kidney function: AST and ALT ≤ 2.0 upper limit of normal values; Bilirubin ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60 mL/min; 5) Functional status
- For patients aged 1-16, the Lansky score is ≥ 60 points.
- For patients over 16 years old, the Karnofsky score is ≥ 60 points. 6) Previous treatment
- Except for emergency mediastinal irradiation (\<1000cGy) due to superior vena cava (SVC) syndrome, Hodgkin's lymphoma guidance treatment was not allowed before.
- 8\) Informed consent
- Patients or their legally authorized guardians must have a thorough understanding of their illness and the nature of the study (including foreseeable risks and possible adverse reactions), and must sign an informed consent form.
Exclusion
- Karnofsky\<60% or Lansky\<60% for individuals under 16 years old.
- Children with Hodgkin's lymphoma who have received other chemical and radiation treatments.
- Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06201507
Start Date
October 1 2022
End Date
December 31 2025
Last Update
January 12 2024
Active Locations (1)
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1
Duan Yanlong
Beijing, China