Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma
The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include: Diagnosed as ALCL, already received first-line treatment, but get disease progression; After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis. Exclusion Criteria: Patients with other systemic diseases, severe infections or critically illness. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Children's Medical Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer Group, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0. | The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0. | 2 years | |
Primary | Progression Rate | The progression rate will be obtained from the results of simple assessment after one course. | 4 weeks | |
Primary | CR/CRu Rate | The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses. | 8 weeks | |
Secondary | Progression-free Survival | 2 years | ||
Secondary | Overall Survival | Compared with historical data. | 2 years |
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