Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT03971318
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival (EFS)', 'timeFrame': 'through study completion, maximal eight years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'through study completion, maximal eight years', 'description': 'OS is defined as time from start of treatment/randomization up to death of any'}, {'measure': 'Relapse-free survival (RFS)', 'timeFrame': 'through study completion, maximal eight years', 'description': '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.'}, {'measure': 'Response rate (RR)', 'timeFrame': 'on an average 3 weeks after finish of treatment', 'description': 'Complete response, partial remission, objective effect, stable disease or progressive disease'}, {'measure': 'Adverse event rate', 'timeFrame': 'through study completion, maximal eight years', 'description': 'Rate of patients with acute toxicity defined as grade III/IV/V AE'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, Non-Hodgkin', 'Lymphoblastic Lymphoma, Childhood', 'PTEN Loss', 'NOTCH1 Gene Mutation', 'Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '23396305', 'type': 'BACKGROUND', 'citation': 'Bonn BR, Rohde M, Zimmermann M, Krieger D, Oschlies I, Niggli F, Wrobel G, Attarbaschi A, Escherich G, Klapper W, Reiter A, Burkhardt B. Incidence and prognostic relevance of genetic variations in T-cell lymphoblastic lymphoma in childhood and adolescence. Blood. 2013 Apr 18;121(16):3153-60. doi: 10.1182/blood-2012-12-474148. Epub 2013 Feb 8.'}, {'pmid': '22547598', 'type': 'RESULT', 'citation': 'Callens C, Baleydier F, Lengline E, Ben Abdelali R, Petit A, Villarese P, Cieslak A, Minard-Colin V, Rullier A, Moreau A, Baruchel A, Schmitt C, Asnafi V, Bertrand Y, Macintyre E. Clinical impact of NOTCH1 and/or FBXW7 mutations, FLASH deletion, and TCR status in pediatric T-cell lymphoblastic lymphoma. J Clin Oncol. 2012 Jun 1;30(16):1966-73. doi: 10.1200/JCO.2011.39.7661. Epub 2012 Apr 30.'}]}, 'descriptionModule': {'briefSummary': "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. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. 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. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..", 'detailedDescription': 'Research purpose:\n\n1. To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.\n2. To explore the feasibility of risk stratification of T-LBL by combining genotyping.\n3. To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.\n4. To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.\n5. To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.\n6. To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'lymphoblastic lymphoma patients#age at diagnosis \\< 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\< 18 years old\n2. Pathologically confirmed lymphoblastic lymphoma\n3. Newly diagnosed patients\n4. Informed consent of guardian of children patients -\n\nExclusion Criteria:\n\n1. Age \\> 18 years old\n2. Recurrent lymphoblastic lymphoma\n3. Secondary immunodeficiency.'}, 'identificationModule': {'nctId': 'NCT03971318', 'briefTitle': 'A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective Multicenter Cohort Study on the Efficacy and Safety of Stratified Treatment of Chinese Children With Lymphoblastic Lymphoma Based on Risk Factors', 'orgStudyIdInfo': {'id': 'SCCCG-LBL-2017-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen zijun', 'role': 'CONTACT', 'email': 'zhenzj@sysucc.org.cn', 'phone': '13609712260', 'phoneExt': '+86'}, {'name': 'Sun xiaofei', 'role': 'CONTACT', 'email': 'sunxf@sysucc.org.cn', 'phone': '13600099837', 'phoneExt': '+86'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhen zijun', 'role': 'CONTACT', 'email': 'zhenzj@sysucc.org.cn', 'phone': '13609712260', 'phoneExt': '+86'}, {'name': 'Sun xiaofei', 'role': 'CONTACT', 'email': 'sunxf@sysucc.org.cn', 'phone': '13600099837', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Zhen zijun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xiao-Fei Sun', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}