BV-AVD-R Treatment Children Hodgkin's Lymphoma

Sponsor
Beijing Children's Hospital
Study ID
NCT06201507
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Jan 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intermediate Risk
    Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
  • Experimental: High Risk
    High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Primary Outcome Measure

Overall Response Rate(ORR) [ Time Frame: Baseline up to end of randomized regimen (approximately 1 year) ]

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