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出境医 / 临床实验 / A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

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

Study Description
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.
Study Design
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

Contacts
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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
Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date May 5, 2017
Estimated Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 2019)
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
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
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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Systemic ALK-positive anaplastic large cell lymphoma patients # age at diagnosis < 18 years.
Condition
  • MRD
  • MDD
  • Lymphoma, Nonhodgkin
  • Anaplastic Lymphoma
  • Pediatric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Burkhardt B, Zimmermann M, Oschlies I, Niggli F, Mann G, Parwaresch R, Riehm H, Schrappe M, Reiter A; BFM Group. The impact of age and gender on biology, clinical features and treatment outcome of non-Hodgkin lymphoma in childhood and adolescence. Br J Haematol. 2005 Oct;131(1):39-49.
  • Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugières L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.
  • Damm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2.
  • Sun X, Zhen Z, Lin S, Zhu J, Wang J, Lu S, Chen Y, Zhang F, Sun F, Li P. Treatment outcome of Chinese children with anaplastic large cell lymphoma by using a modified B-NHL-BFM-90 protocol. Pediatr Hematol Oncol. 2014 Sep;31(6):518-27. doi: 10.3109/08880018.2014.939793. Epub 2014 Aug 12.
  • Le Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugières L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. doi: 10.1200/JCO.2010.28.5999. Epub 2010 Aug 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2019) 		300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 5, 2025
Estimated Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sun Xiao-Fei 13600099837 ext +86 sunxf@sysucc.org.cn
Contact: Zhen Zi-Jun 13609712260 ext +86 zhenzj@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971305
Other Study ID Numbers SCCCG-ALCL-2017-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xiao-Fei Sun, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators
Study Director: Sun Xiaofei Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

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