Clinical trial · Interventional
BV-AVD-R Treatment Children Hodgkin's Lymphoma
Efficacy and Safety of Modified BV-AVD-R Regimen in Chinese Children With Previously Untreated Intermediate- and High-risk Classical Hodgkin's Lymphoma: an Open Label, Non-randomized, Single-arm, Phase 2 Study From Single Center
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intermediate Risk
- description
- Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
- interventionNames
- Drug: Brentuximab vedotin
- Drug: Rituximab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dacarbazine
- type
- EXPERIMENTAL
- label
- High Risk
- description
- High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
- interventionNames
- Drug: Brentuximab vedotin
- Drug: Rituximab
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dacarbazine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available