Back to resultsVinorelbine for Recurrent ACLC
Primary Purpose
Anaplastic Large Cell Lymphoma, Vinorelbine
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma focused on measuring Anaplastic Large Cell Lymphoma, Childhood, Adolescent, Recurrent, Treatment
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.
Sites / Locations
- Shanghai Children's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vinorelbine monotherapy treatment
Arm Description
Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.
Outcomes
Primary Outcome Measures
Event free survival
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT03397953
First Posted
January 6, 2018
Last Updated
July 23, 2022
Sponsor
Children's Cancer Group, China
1. Study Identification
Unique Protocol Identification Number
NCT03397953
Brief Title
Vinorelbine for Recurrent ACLC
Official Title
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Group, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Large Cell Lymphoma, Vinorelbine
Keywords
Anaplastic Large Cell Lymphoma, Childhood, Adolescent, Recurrent, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vinorelbine monotherapy treatment
Arm Type
Experimental
Arm Description
Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.
Description
The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yijin Gao, MD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Children's Medical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Vinorelbine for Recurrent ACLC
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