We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 266768 for:    ALL

Vinorelbine for Recurrent ACLC-2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443128
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2020


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.



Primary Outcome Measures :
  1. Event free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443128


Contacts
Contact: Yijin Gao, MD 86-21-38626161 ext 82064 gaoyijin@scmc.com.cn
Contact: Xingwei Wang, MD 86-21-38626161 wangxingwei@scmc.com.cn

Locations
China, Shanghai
Shanghai Children's Medical Center Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yi-Jin Gao, MD    0086-21-38626161    gaoyijin@scmc.com.cn   
Contact: Xing-Wei Wang, MD    0086-21-38626161    wangxingwei@scmc.com.cn   
Sponsors and Collaborators
Children's Cancer Group, China
Investigators
Principal Investigator: Yijin Gao, MD Shanghai Children's Medical Center

Responsible Party: Children's Cancer Group, China
ClinicalTrials.gov Identifier: NCT03443128     History of Changes
Other Study ID Numbers: CCGChina--R-ALCL-2017
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Cancer Group, China:
Anaplastic Large Cell Lymphoma
Recurrent
Childhood
Adolescent
Treatment

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action