Spots Global Cancer Trial Database for Vinorelbine for Recurrent ACLC
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Trial Identification
Brief Title: Vinorelbine for Recurrent ACLC
Official Title: Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma
Study ID: NCT03397953
Interventions
Study Description
Brief Summary: 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.
Detailed Description: Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Shanghai Children's Medical Center, Shanghai, Shanghai, China
Contact Details
Name: Yijin Gao, MD
Affiliation: Shanghai Children's Medical Center
Role: PRINCIPAL_INVESTIGATOR
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