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Modified ALCL99 Regimen for Chinese Children With Newly Diagnosed High-risk ALCL
NCT04881838Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2021
- Primary completion
- Mar 2026
- Countries
- 1
- Sponsor
- Children's Oncology Group
- Modality
- Small Molecules
- Drugs
- vinorelbine
- Conditions
- anaplastic large cell lymphoma (ALCL)
01
Overview
Phase 3, open-label, single-arm trial of vinorelbine in anaplastic large cell lymphoma (ALCL), sponsored by Children's Oncology Group. Primary endpoints: Event-Free Survival at 3 years and Treatment-related adverse events at 3 years. Started Mar 2021; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
High risk group
Patients receive sequential courses of chemotherapy including vinorelbine.
03
Who it enrols
Patients <= 18 years with newly diagnosed high-risk ALCL, without prior therapy, immunodeficiency, or overwhelming infection.
04
Endpoints
Primary
Event-Free Survival
Treatment-related adverse events
Secondary
Patient compliance
Value of early PET/CT in pediatric ALCL
Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level
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