Vinorelbine for Recurrent ACLC


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.

Full Title of Study: “Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2022

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.


  • Drug: Vinorelbine
    • Vinorelbine will be used 25mg/m2/week, rest for 1 week after 3 weeks of continuous use, 4 weeks will be a course. After 1 week there will be a simple assessment, after 2 weeks will be a comprehensive assessment. If the patient got disease progression or partial response/stable disease, he/she would be removed from this trial.

Arms, Groups and Cohorts

  • Experimental: Vinorelbine monotherapy treatment
    • Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.

Clinical Trial Outcome Measures

Primary Measures

  • Event free survival
    • Time Frame: 5 years

Secondary Measures

  • Overall survival
    • Time Frame: 5 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Cancer Group, China
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yijin Gao, MD, Principal Investigator, Shanghai Children’s Medical Center

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