BV-AVD-R Treatment Children Hodgkin's Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06201507
• Other study ID #: [2022]-E-233-Y
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 44
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Brentuximab vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
• Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.
• Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
• Vincristine
1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
• Dacarbazine
375 mg/m2 will be administered on days 1 and 15

Locations

Country	Name	City	State
China	Duan Yanlong	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Emergent Adverse Event (TEAE)	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)
Primary	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	Progression-free survival(PFS)	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