Vinorelbine for Recurrent ALCL-2017

  • STATUS
    Recruiting
  • End date
    Sep 18, 2025
  • participants needed
    20
  • sponsor
    Children's Cancer Group, China
Updated on 7 October 2022
cancer
stem cell transplantation

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.

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.

Details
Condition Anaplastic Large Cell Lymphoma, Vinorelbine
Treatment Vinorelbine
Clinical Study IdentifierNCT03443128
SponsorChildren's Cancer Group, China
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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