Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05333302
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 month', 'description': 'Adverse events will be graded according to the CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) (CR+CRi+CRm)', 'timeFrame': '28 days after CAR-T cells infusion', 'description': 'The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).'}, {'measure': 'Overall survival (OS)', 'timeFrame': '1 year', 'description': 'The proportion of patients with overall survival'}, {'measure': 'Events free survival (EFS)', 'timeFrame': '1 year', 'description': 'Time from CAR-T cells infusion to CR failure, relapse, or death.'}, {'measure': 'Leukemia free survival (LFS)', 'timeFrame': '1 year', 'description': 'Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'CAR-T cells', 'CD19'], 'conditions': ['B-cell Acute Lymphoblastic Leukemia', 'Lymphoblastic B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.', 'detailedDescription': 'Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* T-cells count in peripheral blood \\>150 cells/µL;\n* Written informed consent.\n\nExclusion Criteria:\n\n* primary immunodeficiencies or genetic syndromes;\n* neurologic diseases;\n* autoimmune diseases or polyallergie;\n* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;\n* GvHD grade 2-4;\n* uncontrolled systemic infection;\n* hypoxia (Sp02\\<90%)\n* severe hepatic dysfunction: ALT or AST \\>=3x upper limit of normal for age;\n* renal dysfunction: serum creatinine level \\>=3x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT05333302', 'briefTitle': 'Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology'}, 'officialTitle': 'Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults', 'orgStudyIdInfo': {'id': 'CD19CAR-T_LL_children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD19 CAR-T cells immunotherapy', 'description': 'After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells', 'interventionNames': ['Biological: CD19 CAR-T-cells', 'Drug: Tocilizumab']}], 'interventions': [{'name': 'CD19 CAR-T-cells', 'type': 'BIOLOGICAL', 'description': 'One dose of CD19 CAR-T cells (1\\*10e6 CAR+ T-cells/kg) by intravenous infusion.', 'armGroupLabels': ['CD19 CAR-T cells immunotherapy']}, {'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['Actemra'], 'description': 'Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).', 'armGroupLabels': ['CD19 CAR-T cells immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223053', 'city': 'Minsk', 'state': 'Minsk Oblast', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Elena Lukoyko, MD', 'role': 'CONTACT', 'phone': '+37529 1643075'}], 'facility': 'Belarussian Research Center for Pediatric Oncology, Hematology and Immunology'}], 'centralContacts': [{'name': 'Elena Lukoyko, MD', 'role': 'CONTACT', 'email': 'lenalukojko@gmail.com', 'phone': '+375291643075'}, {'name': 'Aleksandr Meleshko, PhD', 'role': 'CONTACT', 'email': 'meleshko@tut.by', 'phone': '+375296940023'}], 'overallOfficials': [{'name': 'Olga Aleinikova, MD, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}