Vinorelbine for Recurrent ACLC

July 23, 2022 updated by: Children's Cancer Group, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.
Time Frame: 2 years
The investigators will record the adverse reactions during the trial through NCI CTCAE version 4.0.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

July 1, 2022

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCGChina-ALCL-ABANDONED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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