Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 882 for:    "Reticulum Cell Sarcoma"

A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

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: NCT03971305
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Xiao-Fei Sun, Sun Yat-sen University

Brief Summary:
With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen,etc.

Condition or disease
MRD MDD Lymphoma, Nonhodgkin Anaplastic Lymphoma Pediatric Cancer

Detailed Description:

Research purpose:

  1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma.
  2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival.
  3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD.
  4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : May 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: through study completion, maximal eight years ]
    EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: through study completion, maximal eight years ]
    OS is defined as time from start of treatment/randomization up to death of any

  2. Relapse-free survival (RFS) [ Time Frame: through study completion, maximal eight years ]
    RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse.

  3. Response rate (RR) [ Time Frame: on an average 3 weeks after finish of treatment ]
    Complete response, partial remission, objective effect, stable disease or progressive disease

  4. Adverse event rate [ Time Frame: from the first day of protocol defined treatment until two years after start of protocol defined treatment ]
    Rate of patients with acute toxicity defined as grade III/IV/V AE



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.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Systemic ALK-positive anaplastic large cell lymphoma patients # age at diagnosis < 18 years.
Criteria

Inclusion Criteria:

  1. Age < 18 years old
  2. Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
  3. Newly diagnosed patients
  4. Informed consent of guardian of children patients

Exclusion Criteria:

  1. Secondary immunodeficiency disease
  2. Second neoplasm
  3. Primary cutaneous anaplastic large cell lymphoma
  4. Recurrent and progressive patients.

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): NCT03971305


Contacts
Layout table for location contacts
Contact: Sun Xiao-Fei 13600099837 ext +86 sunxf@sysucc.org.cn
Contact: Zhen Zi-Jun 13609712260 ext +86 zhenzj@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Sun Xiaofei    13600099837 ext +86    sunxf@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Study Director: Sun Xiaofei Sun Yat-sen University

Publications of Results:

Layout table for additonal information
Responsible Party: Xiao-Fei Sun, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03971305     History of Changes
Other Study ID Numbers: SCCCG-ALCL-2017-001
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases