Hodgkin Lymphoma
Conditions
Keywords
CD30, Brentuximab vedotin, Children, Hodgkin lymphoma, Efficacy, Safety
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 questions it aims to answer are: * \[Overall Response Rate(ORR) :Complete Response(CR)+Partial Response(PR)\] * \[progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.\] Participants will be given modified BV-AVD-R regimen according to rapid early responders (RER) or slow early responders (SER) after 2 cycles.
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 undergo Positron Emission Tomography(PET)/Computed Tomography(CT) at the time of initial diagnosis and after 2 cycles of modified BV+R+AVD regimen to determine early response. Rapid early responders (RER) defined as CR after 2 cycles of therapy. Slow early responders (SER) defined as no CR (partial response (PR) or stable disease) after 2 cycles of therapy. Intermediate-risk patients were stage IA bulk/E, IB, IIA bulk/E, IIB, and IIIA. High-risk patients were stage IIB bulk/E, IIIA bulk/E, IIIB, and IVA/B. The primary endpoints include ORR (CR+PR) and adverse events. The secondary endpoints include progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.
Interventions
DRUGBrentuximab vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
DRUGRituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
DRUGDoxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
DRUGVincristine
1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
DRUGDacarbazine
375 mg/m2 will be administered on days 1 and 15
Sponsors
Beijing Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≤ 18 years old, regardless of gender; 2. According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive; 3. Newly diagnosed classic Hodgkin's lymphoma: all stages 4. 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 criteria
1. Karnofsky\<60% or Lansky\<60% for individuals under 16 years old. 2. Children with Hodgkin's lymphoma who have received other chemical and radiation treatments. 3. Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate(ORR) | Baseline up to end of randomized regimen (approximately 1 year) | disease evaluations will be performed by PET-CT at the end of randomized regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 6 month and 1 year after the end of treatment | disease evaluations will be performed at at 6 months and 1 year after the end of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Event (TEAE) | Baseline up to 30 days after last dose of study drug (approximately 1 year) | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |
Countries
China
Outcome results
None listed