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Vinorelbine for Recurrent ALCL-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. Identifier: NCT03443128
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : July 30, 2021
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.

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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 2024
Estimated Study Completion Date : September 2025

Arm Intervention/treatment
Experimental: Vinorelbine monotherapy treatment
Patients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total.
Drug: Vinorelbine
During each course, patients will be treated with vinorelbine (25mg/m2/week on weeks 1-3). After 1 course(4 weeks) of vinorelbine, response will be evaluated by simple assessment: clinical symptoms, signs, B ultrasound, chest X-ray, peripheral blood test and bone marrow smear(if needed). After 2 courses, response will be evaluatedy by simple assessment, CT and FDG-PET. The CR/CRu was defined by anatomic tumour shrinkage more than 75% after 2 courses based on CT with negative PET assessment, with negative bone marrow PCR(if needed) and without CNS involvement. Patients who achieved a CR/CRu after two courses either will proceed to stem cell transplantation (SCT) or will receive additional courses of therapy while awaiting SCT. Response was re-evaluated at the end of every 2 courses. Patients with progressive disease at any time during treatment will be removed from protocol therapy.

Primary Outcome Measures :
  1. Progression Rate [ Time Frame: 4 weeks ]
    The progression rate will be obtained from the results of simple assessment after one course.

  2. CR/CRu Rate [ Time Frame: 8 weeks ]
    The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses.

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 2 years ]
  2. Overall Survival [ Time Frame: 2 years ]
    Compared with historical data.

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.

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

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 identifier (NCT number): NCT03443128

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Contact: Yijin Gao, MD 86-21-38626161 ext 82064
Contact: Xingwei Wang, MD 86-21-38626161

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China, Shanghai
Shanghai Children's Medical Center Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yi-Jin Gao, MD    0086-21-38626161   
Contact: Xing-Wei Wang, MD    0086-21-38626161   
Sponsors and Collaborators
Children's Cancer Group, China
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Principal Investigator: Yijin Gao, MD Shanghai Children's Medical Center
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Responsible Party: Children's Cancer Group, China Identifier: NCT03443128    
Other Study ID Numbers: CCGChina-R-ALCL-2017
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021

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