[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492604":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":69,"collaborators":20,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":20,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":20,"enrollmentInfo":80,"targetDuration":20,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ibrutinib","EXPERIMENTAL","Patients will receive ibrutinib 420 mg\u002Fday orally for up to 12 cycles of 28 days.",[13],"Drug: Ibrutinib 420 mg",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ibrutinib 420 mg","Patients will receive ibrutinib orally on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of CLL progression or unacceptable toxicity.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Paola Fazi","CONTACT","0670390528","p.fazi@gimema.it",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Enrico Crea","0670390514","e.crea@gimema.it",[32,47,58],{"facility":33,"status":34,"city":35,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ematologia Osp Careggi","RECRUITING","Florence","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.24626,43.77925,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":20,"phoneExt":20,"email":20},"Alessandro Sanna",{"facility":48,"status":34,"city":49,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Ematologia Osp Maggiore della Carità","Novara",{"type":39,"coordinates":51},[52,53],8.62118,45.44694,{"lat":53,"lon":52},[56],{"name":57,"role":24,"phone":20,"phoneExt":20,"email":20},"Riccardo Moia",{"facility":59,"status":34,"city":60,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Ematologia Osp Molinette","Torino",{"type":39,"coordinates":62},[63,64],11.99138,44.88856,{"lat":64,"lon":63},[67],{"name":68,"role":24,"phone":20,"phoneExt":20,"email":20},"Marta Coscia",{"type":70,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100492604","phase-2-ibrutinib-for-the-treatment-of-aiha-in-patients-with-cllsll-or-cll-like-mbl-100492604",false,"NCT05694312","Ibrutinib for the Treatment of AIHA in Patients With CLL\u002FSLL or CLL-like MBL","Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis","Inclusion Criteria:\n\n1. Diagnosis of CLL\u002Fsmall lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.\n2. Patients \\>18 years old\n3. Active AIHA (wAIHA or CAD) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg\u002Fkg predniso(lo)ne), or iii) is steroid-dependent (need to continue on predniso(lo)ne at a dose of \\>10 mg\u002Fday to maintain a response). AIHA is defined as: anemia (hemoglobin ≤10 g\u002FdL; or hemoglobin \\>10 g\u002FdL dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive DAT (either IgG DAT, C3 DAT or both).\n4. Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.\n5. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n\nExclusion Criteria:\n\n1. Contraindication to ibrutinib therapy as per treating physician's discretion.\n2. Contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin K antagonists).\n3. Previous exposure to ibrutinib as CLL-directed therapy.\n4. Other CLL\u002FSLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.\n5. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.","ALL","18 Years",{"count":81,"type":82},45,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL\u002FSLL or CLL-like MBL.",[88,89,90,91],"Autoimmune Hemolytic Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Monoclonal B-Cell Lymphocytosis CLL-Type","2023-11-28",{"date":94,"type":95},"2023-12-01","ACTUAL",{"date":97,"type":95},"2023-11-24",{"date":99,"type":82},"2026-11",{"name":5,"class":6},3]