BV-AVD-R Treatment Children Hodgkin's Lymphoma

Trial Title: BV-AVD-R Treatment Children Hodgkin's Lymphoma

NCT ID: NCT06201507

Condition: Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma
Hodgkin Disease
Rituximab
Brentuximab Vedotin
Doxorubicin
Vincristine
Dacarbazine

Conditions: Keywords:
CD30
Brentuximab vedotin
Children
Hodgkin lymphoma
Efficacy
Safety

Study type: Interventional

Study phase: Phase 2

Overall status: Enrolling by invitation

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Brentuximab vedotin
Description: Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Arm group label: High Risk
Arm group label: Intermediate Risk

Other name: Adcetris

Intervention type: Drug
Intervention name: Rituximab
Description: Days: 2 and 16 Dose: 375 mg/m2/dose.
Arm group label: High Risk
Arm group label: Intermediate Risk

Other name: Rituxan

Intervention type: Drug
Intervention name: Doxorubicin
Description: Days: 1 and 15 Dose: 25 mg/m2/dose.
Arm group label: High Risk
Arm group label: Intermediate Risk

Other name: Doxil, Adriamycin

Intervention type: Drug
Intervention name: Vincristine
Description: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Arm group label: High Risk
Arm group label: Intermediate Risk

Other name: Oncovin

Intervention type: Drug
Intervention name: Dacarbazine
Description: 375 mg/m2 will be administered on days 1 and 15
Arm group label: High Risk
Arm group label: Intermediate Risk

Other name: DTIC

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.

Criteria for eligibility:
Criteria:
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)

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: Duan Yanlong

Address:
City: Beijing
Country: China

Start date: October 1, 2022

Completion date: December 31, 2025

Lead sponsor:
Agency: Beijing Children's Hospital
Agency class: Other

Source: Beijing Children's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06201507