Vinorelbine for Recurrent ACLC

Phase 2

Completed

• Conditions: Anaplastic Large Cell Lymphoma; Vinorelbine
• Interventions: Drug: Vinorelbine

• Registration Number: NCT03397953
• Lead Sponsor: Children's Cancer Group, China

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-07-23
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vinorelbine monotherapy treatment	Vinorelbine	Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.

Primary Outcome Measures

Name	Time	Method
Event free survival	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, Shanghai, China