Vinorelbine for Recurrent ACLC

Sponsor

Children's Cancer Group, China (Other)

Overall Status

Completed

CT.gov ID

NCT03397953

Collaborator

(none)

Enrollment

Location

Arm

67.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anaplastic Large Cell Lymphoma Vinorelbine	Drug: Vinorelbine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vinorelbine monotherapy treatment

Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.

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.

Outcome Measures

Primary Outcome Measures

Event free survival [5 years]

Secondary Outcome Measures

Overall survival [5 years]

Other Outcome Measures

Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0. [2 years]
The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.