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BV-AVD-R Treatment Children Hodgkin's Lymphoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT06201507•Beijing Children's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 1, 2022

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2025

Last Updated

January 12, 2024

Enrollment

ESTIMATED participants

Conditions

Hodgkin Lymphoma

Interventions

Brentuximab vedotin

DRUG

Rituximab

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Dacarbazine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BV-AVD-R Treatment Children Hodgkin's Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

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