Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-28 @ 7:27 PM
Study NCT ID:
NCT04289103
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C079843', 'term': 'inolimomab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response', 'timeFrame': 'Day 29 post inclusion', 'description': 'Complete response + very good partial response + partial response'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Steroid Refractory GVHD']}, 'descriptionModule': {'briefSummary': 'A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)\n* Age 28 days to \\< 18 years old\n* Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen\n* Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)\n* Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Isolated stage 1 skin SR-aGvHD\n* Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)\n* Acute GvHD after donor lymphocytes infusion (DLI)\n* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal\n* Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Known allergy or intolerance to Leukotac of one of its ingredients\n* Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential\n* Other ongoing interventional protocol that might interfere with"}, 'identificationModule': {'nctId': 'NCT04289103', 'acronym': 'EiFFEL', 'briefTitle': 'Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'ElsaLys Biotech'}, 'officialTitle': 'A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD)', 'orgStudyIdInfo': {'id': 'INO-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inolimomab/Leukotac', 'description': "* Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study.\n* Treatment phase - Leukotac will be given up to D28\n* Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion", 'interventionNames': ['Biological: Inolimomab (Leukotac)']}], 'interventions': [{'name': 'Inolimomab (Leukotac)', 'type': 'BIOLOGICAL', 'description': "* Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study.\n* Treatment phase - Leukotac will be given up to D28\n* Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion.", 'armGroupLabels': ['Inolimomab/Leukotac']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ElsaLys Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}