BV-AVD-R Treatment Children Hodgkin's Lymphoma

January 10, 2024 updated by: Duan Yanlong, Beijing Children's Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Duan Yanlong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Names:
  • Doxil, Adriamycin
Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Names:
  • Rituxan
Drug: Brentuximab vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Other Names:
  • Adcetris
Drug: Vincristine
1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Names:
  • Oncovin
Drug: Dacarbazine
375 mg/m2 will be administered on days 1 and 15
Other Names:
  • DTIC
Experimental: High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
Drug: Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
Other Names:
  • Doxil, Adriamycin
Drug: Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
Other Names:
  • Rituxan
Drug: Brentuximab vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Other Names:
  • Adcetris
Drug: Vincristine
1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Other Names:
  • Oncovin
Drug: Dacarbazine
375 mg/m2 will be administered on days 1 and 15
Other Names:
  • DTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate(ORR)
Time Frame: Baseline up to end of randomized regimen (approximately 1 year)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: 6 month and 1 year after the end of treatment
disease evaluations will be performed at at 6 months and 1 year after the end of treatment
6 month and 1 year after the end of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Event (TEAE)
Time Frame: Baseline up to 30 days after last dose of study drug (approximately 1 year)
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Baseline up to 30 days after last dose of study drug (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

  • Study Chair: Yanlong Duan, Beijing Children hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2022]-E-233-Y

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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