Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 5:23 PM
Study NCT ID:
NCT04055558
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2019-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2019-08-11', 'studyFirstSubmitQcDate': '2019-08-11', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probability of survival', 'timeFrame': '1 year', 'description': 'Assess six-month probability of survival since LPD diagnosis'}], 'secondaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': '5 years', 'description': 'Assess 5-year event-free survival since acute lymphoblastic leukemia/lymphoma diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['childhood leukemia', 'lymphoproliferative disorders', 'EBV'], 'conditions': ['Childhood Leukemia and Lymphoma']}, 'descriptionModule': {'briefSummary': 'Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. There have been isolated case reports of patients with childhood ALL who developed LPD after ALL diagnosis, without undergoing stem cell transplantation, but data regarding such cases are limited. We propose here an international collaboration, to form a comprehensive database of children who developed LPD after diagnosis of acute lymphoblastic leukemia/lymphoma', 'detailedDescription': "Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. These disorders have been extensively described in the post-transplant setting, ie after hematopoietic stem cell (SCT) or solid organ (SOT) transplant. However, since the 1980's, there have been isolated case reports of patients with childhood ALL, who developed LPD after diagnosis of ALL, without undergoing SCT. Comprehensive information is unavailable regarding the prevalence, clinical manifestations, treatment, outcome and pathogenesis of such disorders in this setting. We propose here an international collaboration, to form a comprehensive database of children who developed LPD during the treatment of acute lymphoblastic leukemia/lymphoma (ALL/LBL).\n\nInformation will be collected in a de-identified fashion regarding patient characteristics, leukemia and LPD characteristics, treatment and outcome. The aims of this retrospective study are:\n\n1. To build a database of children who developed LPD after diagnosis of ALL/LBL\n2. To investigate the characteristics and outcome of this disorder"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and young adults (\\<30 years of age), previously diagnosed with acute lymphoblastic leukemia/lymphoma, who developed LPD after ALL/LBL diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed LPD after ALL/LBL diagnosis\n\nExclusion Criteria:\n\n* age\\>30 years'}, 'identificationModule': {'nctId': 'NCT04055558', 'briefTitle': 'Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma', 'orgStudyIdInfo': {'id': 'RMC-0109-17'}}, 'contactsLocationsModule': {'locations': [{'zip': '4920235', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sarah Elitzur, MD', 'role': 'CONTACT', 'email': 'sarhae@clalit.org.il', 'phone': '97239253669'}, {'name': 'Naomi Litichever, PhD', 'role': 'CONTACT', 'email': 'naomilitichever@clalit.org.il', 'phone': '97239253669'}], 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '4920235', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sarah Elitzur, MD', 'role': 'CONTACT', 'email': 'sarhae@clalit.org.il'}, {'name': 'Naomi Litichever, PhD', 'role': 'CONTACT', 'email': 'naomilitichever@clalit.org.il'}], 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Sarah Elitzur, MD', 'role': 'CONTACT', 'email': 'sarhae@clalit.org.il', 'phone': '97239253669'}, {'name': 'Naomi Litichever, PhD', 'role': 'CONTACT', 'email': 'naomilitichever@clalit.org.il', 'phone': '97239253669'}], 'overallOfficials': [{'name': 'Sarah Elitzur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Schneider Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Israeli Society for Pediatric Hematology-Oncology', 'class': 'OTHER'}, {'name': 'International BFM Study Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}