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

First listed
Jan 11, 2024
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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