BV-AVD-R Treatment Children Hodgkin's Lymphoma
NCT06201507 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-01-12
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
Interventions
- DRUG
-
Brentuximab vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
- DRUG
-
Days: 2 and 16 Dose: 375 mg/m2/dose.
- DRUG
-
Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
- DRUG
-
Vincristine
1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
- DRUG
-
Dacarbazine
375 mg/m2 will be administered on days 1 and 15
Sponsors & Collaborators
-
Beijing Children's Hospital
lead OTHER
Principal Investigators
-
Yanlong Duan · Beijing Children Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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