Trials / Completed
CompletedNCT03397953
Vinorelbine for Recurrent ACLC
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Children's Cancer Group, China · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
- First posted
- 2018-01-12
- Last updated
- 2022-07-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03397953. Inclusion in this directory is not an endorsement.