Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT02577094
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2015-10-02', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the maximum tolerated dose (MTD)', 'timeFrame': '6 weeks', 'description': 'Patient toxicity will be evaluated according to NTCAE V4 criteria.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Month 12'}, {'measure': 'Disease free survival at one year post-transplant', 'timeFrame': 'Month 12'}, {'measure': 'Incidence of relapse at 1 year post-transplant', 'timeFrame': 'Month 12'}, {'measure': 'Non relapse mortality at day 100 post-transplant', 'timeFrame': 'Day 100'}, {'measure': 'Non relapse mortality at one year post-transplant', 'timeFrame': 'Month 12'}, {'measure': 'Hematologic reconstitutions post-transplant', 'timeFrame': 'Month 3', 'description': 'Biological follow-up'}, {'measure': 'Immune reconstitutions post-transplant', 'timeFrame': 'Month 3', 'description': 'Biological follow-up'}, {'measure': 'Incidence of acute and chronic GVHD', 'timeFrame': 'Month 3 and 12'}, {'measure': 'Chimerism post-transplant', 'timeFrame': 'Month 3', 'description': 'Blood sample and/or bone marrow analysis by molecular biology'}, {'measure': 'Residual disease post-transplant', 'timeFrame': 'Month 3 and Month 12', 'description': 'by flow cytometry analysis'}, {'measure': 'Toxicity of RIT', 'timeFrame': 'Week 6 and Month 12', 'description': 'biological follow up and physical examination'}, {'measure': 'Tolerance of RIT', 'timeFrame': 'Week 6 and Month 12', 'description': 'biological follow up and physical examination'}, {'measure': 'Immunization analysis : detection of antibody anti epratuzumab', 'timeFrame': 'Month 12', 'description': 'By ELISA assay'}, {'measure': '90Y-DOTA-Epratuzumab blood pharmacokinetics', 'timeFrame': 'Month 2', 'description': "Detection of the radioactivity within the patient's blood samples"}, {'measure': 'Dosage of FLT3-ligand in plasma and correlation with efficacy and toxicity of RIT', 'timeFrame': 'Month 12', 'description': 'by biological assay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CD22 positive- lymphoblastic leukemia-RIT-Yttrium'], 'conditions': ['Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2 before allogeneic stem cell transplantation.', 'detailedDescription': '* Physical examination (screening and follow-up)\n* Complete blood counts (screening and follow-up)\n* Dosage of FLT3-ligand in plasma (screening and follow-up)\n* Blood ionogramme, creatinine hepatic work-up (screening and follow-up)\n* Left ventricular ejection fraction at pre-implant assessment\n* Immunization test (screening and follow-up)\n* Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)\n* All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.\n* Pharmacokinetic of 90Y-hLL2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk\n* B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1.\n* Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage.\n* HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization\n* ECOG (Eastern Cooperative Oncology Group) ≤ 2\n* Having or not received previously Epratuzumab\n* Eligible for an allograft with reduced conditioning regimen\n* With a signed informed consent\n* Patient in age of children bearing with adequate contraception\n* Patient affiliated to or beneficiary of the National Health Service\n\nExclusion Criteria:\n\n* T-cell ALL\n* Known hypersensibility to 90Y-DOTA-hLL2\n* Immunization against hLL2 for patients having already received one or several injections of this antibody\n* Patient eligible for myeloablative conditioning regimen\n* Other prior malignancies must have had at least a 2-year disease-free interval with the exception of successfully treated carcinoma skin cancer or carcinoma in situ of the cervix.\n* Patient with progressive psychiatric condition.\n* HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment\n* Pregnant or breast-feeding women\n* Women with childbearing potential without effective contraception\n* Serious concomitant and uncontrolled infection\n* Usual contraindications in the allogeneic transplant:\n* Adult patient protected by the French law'}, 'identificationModule': {'nctId': 'NCT02577094', 'acronym': 'EPRALLO', 'briefTitle': 'Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'orgStudyIdInfo': {'id': 'RC14_0429'}}, 'armsInterventionsModule': {'interventions': [{'name': '90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG', 'type': 'DRUG', 'otherNames': ['90Y-DOTA- hLL2 IgG and hLL2 IgG'], 'description': '2 injections of 90Y-DOTA- hLL2 IgG- hLL2 IgG at day -21 and day -14. (The 2 drugs are mixted in the same infusion)'}, {'name': 'Busulfan', 'type': 'DRUG', 'description': 'Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation'}, {'name': 'allogeneic stem cell transplantation.', 'type': 'BIOLOGICAL', 'description': 'At Day 0'}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation'}, {'name': 'Thymoglobulines', 'type': 'BIOLOGICAL', 'description': 'Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}