BV-AVD-R Treatment Children Hodgkin's Lymphoma

Phase 2UnknownNCT06201507

Beijing Children's Hospital44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

Brentuximab vedotinDRUG

Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)

RituximabDRUG

Days: 2 and 16 Dose: 375 mg/m2/dose.

DoxorubicinDRUG

Days: 1 and 15 Dose: 25 mg/m2/dose.

Vincristine

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Duan Yanlong

Beijing, China

Outcomes

Primary Outcomes

Overall Response Rate(ORR)

disease evaluations will be performed by PET-CT at the end of randomized regimen

Time frame: Baseline up to end of randomized regimen (approximately 1 year)

Secondary Outcomes

Progression-free survival(PFS)

disease evaluations will be performed at at 6 months and 1 year after the end of treatment

Time frame: 6 month and 1 year after the end of treatment

Data from ClinicalTrials.gov

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