BV-AVD-R Treatment Children Hodgkin's Lymphoma

NCT06201507 | Unknown Phase 2 DMC

• 1 other identifier: [2022]-E-233-Y
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

CD30; Brentuximab vedotin; Children; Hodgkin lymphoma; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate(ORR)

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

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

Secondary Outcomes (1)

• Progression-free survival(PFS)

  6 month and 1 year after the end of treatment

Other Outcomes (1)

• Treatment Emergent Adverse Event (TEAE)

  Baseline up to 30 days after last dose of study drug (approximately 1 year)

Study Arms (2)

Intermediate Risk

EXPERIMENTAL

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Dacarbazine

High Risk

EXPERIMENTAL

High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Dacarbazine

Interventions

Brentuximab vedotin DRUG

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

Also known as: Adcetris

High Risk; Intermediate Risk

Rituximab DRUG

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

Also known as: Rituxan

High Risk; Intermediate Risk

Doxorubicin DRUG

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

Also known as: Doxil, Adriamycin

High Risk; Intermediate Risk

Vincristine DRUG

1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).

Also known as: Oncovin

High Risk; Intermediate Risk

Dacarbazine DRUG

375 mg/m2 will be administered on days 1 and 15

Also known as: DTIC

High Risk; Intermediate Risk

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≤ 18 years old, regardless of gender;
• According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive;
• Newly diagnosed classic Hodgkin's lymphoma: all stages
• 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.
• \) 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.

You may not qualify if:

• Karnofsky\<60% or Lansky\<60% for individuals under 16 years old.
• Children with Hodgkin's lymphoma who have received other chemical and radiation treatments.
• Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Duan Yanlong

Beijing, China

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin; Rituximab; Doxorubicin; liposomal doxorubicin; Vincristine; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Yanlong Duan

  Beijing Children Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocoate chief physician

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 11, 2024
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)