Vinorelbine for Recurrent ACLC

Anaplastic Large Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397953
• Other study ID #: CCGChina-ALCL-ABANDONED
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: Children's Cancer Group, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Vinorelbine

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Group, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.	The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.	2 years
Primary	Event free survival		5 years
Secondary	Overall survival		5 years