Vinorelbine for Recurrent ACLC

Study Overview
=================
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.

Official Title
-----------------
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma

Conditions
-----------------
Anaplastic Large Cell Lymphoma, Vinorelbine

Intervention / Treatment
-----------------
* Drug: Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vinorelbine monotherapy treatment<br>Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total. | Drug: Vinorelbine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaplastic Large Cell Lymphoma, Childhood, Adolescent, Recurrent, Treatment