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Vinorelbine for Recurrent ALCL in Children
NCT03443128Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2016
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Children's Oncology Group
- Modality
- Small Molecules
- Drugs
- vinorelbine
- Conditions
- anaplastic large cell lymphoma (ALCL)
01
Overview
Phase 2, open-label, single-arm trial of vinorelbine in anaplastic large cell lymphoma (ALCL), sponsored by Children's Oncology Group. Primary endpoints: Progression Rate at 4 weeks and Complete Remission/Unconfirmed Complete Remission Rate at 8 weeks. Started Nov 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Vinorelbine Monotherapy
Patients receive Vinorelbine monotherapy for up to 20 courses.
03
Who it enrols
Children and adolescents with recurrent or progressive ALCL who have received first-line treatment.
04
Endpoints
Primary
Progression Rate
Complete Remission/Unconfirmed Complete Remission Rate
Secondary
Progression-free Survival
Overall Survival
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