[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gruppo Italiano Malattie EMatologiche dell'Adulto\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":591},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,40,68,90,115,143,168,192,220,243,264,292,321,350,370,390,411,438,460,481,503,525,550,569],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100599167","observational-study-on-apl-like-acute-myeloid-leukemia-distinct-phenotype-and-early-vascular-complications-100599167",false,"NCT07080970","Observational Study on APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions","Observational Study on APL-like Subset Within NPM1-mutated Acute Myeloid Leukemia: a Distinct Phenotypic Signature Correlating With Early-onset Vascular Complications. ACTIVATE (APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions)","ACTIVATE","Inclusion Criteria:\n\n* Patients with de novo AML, untreated, newly diagnosed, according to WHO\u002FICC 2022 criteria from January 2015 onwards.\n* Presence of NPM1 mutation.\n* Availability of immunophenotypic characterization at diagnosis\n* Age \\>= 18 years\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws (if applicable)\n\nExclusion Criteria:\n\n* No specific exclusion criteria are provided once eligibility criteria are met.","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","OBSERVATIONAL","This is a multicenter observational study with a retrospective and a prospective cohort investigating clinically and biologically the APL-like subset as a potential predictor of coagulopathy and susceptibility to early vascular events.",[25,26],"Acute Myeloid Leukemia","NPM1 Mutation","RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":21},"2026-07",{"date":35,"type":21},"2028-11",{"name":37,"class":38},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100642928","efficacy-of-asciminib-in-real-world-in-patients-with-chronic-myeloid-leukemia-in-second-or-subsequent-lines-100642928","NCT07640750","Efficacy of Asciminib in Real-world in Patients With Chronic Myeloid Leukemia in Second or Subsequent Lines","Retrospective and Prospective Observational Study on the Efficacy and Tolerability of Asciminib in Real-world Clinical Practice in Patients With Chronic Myeloid Leukemia Treated in Second or Subsequent Lines: ASCIRLI (ASCIminib in Real-Life Italy)","ASCIRLI","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years and no upper age limit;\n2. Patients with a diagnosis of CML-CP who started treatment with asciminib according to clinical practice - from the date of commercial availability of asciminib - until the end of recruitment period (two years after the first patient included);\n3. Patients treated with asciminib in second or subsequent lines of therapy (≥2L)\n4. Patients who provide written informed consent to participate in the study (if applicable).\n\nExclusion Criteria:\n\n* None",{"count":49,"type":21},98,"The goal of this observational study is to evaluate the efficacy and tolerability of asciminib in real-life in patients with chronic myeloid leukemia treated in second or subsequent lines. The main object of the study is to assess the achievement of Major Molecular Response.",[52,53],"Chronic Myeloid Leukemia","Chronic Myeloid Leukemia - Chronic Phase",[55,56,57,58],"chronic myeloid leukemia","asciminib","real-life","second line","NOT_YET_RECRUITING","2026-06-08",{"date":62,"type":31},"2026-06-11",{"date":64,"type":21},"2026-09-01",{"date":66,"type":21},"2031-12-01",{"name":37,"class":38},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100639269","car-t-treatment-in-pediatric-and-adult-acute-lymphoblastic-leukemia-100639269","NCT07623655","CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia","Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Diagnosis of ALL R\u002FR CD19+\n2. Patients are pediatric (all patients up to the age of 18) adult (all comers older than 18)\n3. Prescribed treatment with Tisagenlecleucel or Brexucabtagene autoleucel as per approved AIFA criteria, or obecabtagene autoleucel - as well as other products - when available\n4. Provided consent (or did not opposed) for collection and use of patient data per local regulations\n\nExclusion Criteria:\n\nNone\n\n\\-",{"count":76,"type":21},107,"The goal of this observational study is to evaluate the efficacy of the treatment with approved CAR-T cells in Italy in pediatric and adult patients with acute B-cell lymphoblastic leukemia. The main question it aims to answer is:\n\nwhich is the overall response rate in pediatric and adult patients with acute B-cell lymphoblastic leukemia treated with approved CAR-T cells?\n\nData will be extracted from patients medical records.",[79,80],"Acute Lymphoblastic Leukemia","B-Cell Acute Lymphoblastic Leukaemia",[82],"CAR-T cell, pediatric, adult","2026-05-29",{"date":85,"type":31},"2026-06-03",{"date":64,"type":21},{"date":88,"type":21},"2029-12-30",{"name":37,"class":38},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100636318","infection-surveillance-of-rr-multiple-myeloma-patients-treated-with-elranatamab-as-clinical-practice-in-italy-100636318","NCT07564128","Infection Surveillance of R\u002FR Multiple Myeloma Patients Treated With Elranatamab as Clinical Practice in Italy","An Italian Registry for Infection Surveillance of Patients Undergoing Salvage Treatment With Elranatamab Monotherapy","RISE","Inclusion criteria:\n\n* adult patients (age \\>18 years) with no upper age limit\n* confirmed Relapsed and Refractory Multiple Myeloma (RRMM) according to IMWG criteria (demonstrated disease progression on the last therapy (progressed on or within 60 days of last therapy).\n* Patients must have received at least three (3) prior lines of therapy, including at least: one Immunomodulatory agent (e.g., Lenalidomide, Pomalidomide), one Proteasome Inhibitor (e.g., Bortezomib, Carfilzomib), one Anti-CD38 Monoclonal Antibody (e.g., Daratumumab, Isatuximab).\n* Treatment with elranatamab within standard clinical practice\n* Written informed consent signature\n\nExclusion Criteria:\n\nnone",{"count":99,"type":21},50,"The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed\u002FRefractory Multiple Myeloma.",[102],"Multiple Mieloma",[104,105,106],"Relapsed\u002FRefractory Multiple Myeloma","Infection Surveillance","Elranatamab","2026-04-27",{"date":109,"type":31},"2026-05-04",{"date":111,"type":21},"2026-08",{"date":113,"type":21},"2028-02",{"name":37,"class":38},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100620387","evaluation-of-the-efficacy-of-ponatinib-in-ph-all-in-the-real-world-100620387","NCT07356960","Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world","Retrospective, Observational, Study on the Evaluation of the Real-world Outcome of Philadelphia-positive Acute Lymphoblastic Leukaemia Patients Treated With Ponatinib as First-line Treatment Under the Italian Law 648\u002F96 (PONA4ALL Ph+)","PONA4ALL Ph+","Inclusion Criteria:\n\n1. Patient is \\> 18 years old;\n2. Patient was treated in first-line with ponatinib monotherapy or in association with chemotherapy or immunotherapy;\n3. Patient received ponatinib under the regulations of Law 648\u002F96;\n4. \\- Patient is alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR\n\n   \\- has died\u002Flost to follow-up at any time after treatment initiation, regardless of the length of available follow-up;\n5. Signed informed consent, if applicable.\n\nExclusion Criteria:\n\n* None",{"count":124,"type":21},103,"The goal of this retrospective observational study is to learn about the efficacy of ponatinib in Philadelphia-positive ALL (Ph+ ALL) patients in a real-world setting. The main goal of the study is to assess the rate of complete molecular response (CMR) induced by ponatinib in patients treated under the regulations of Law 648\u002F96, outside clinical trials.\n\nPatients who were treated with ponatinib as part of their regular medical care and completed the follow-up period will be included in the study.",[127,128],"Acute Lymphobkastic Leukemia","Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[130,131,132,133,134],"ponatinib","real-world","philadelphia-positive acute lymphoblastic leukemia","Ph+ ALL","adult","2026-01-12",{"date":137,"type":31},"2026-01-21",{"date":139,"type":21},"2026-04-02",{"date":141,"type":21},"2029-06-30",{"name":37,"class":38},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100612132","momelotinib-effectiveness-in-myelofibrosis-100612132","NCT07249606","Momelotinib Effectiveness in Myelofibrosis","Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)","Inclusion Criteria:\n\n1. Patients aged 18 years or older.\n2. Patients diagnosed with primary or post-polycythemia vera\u002Fpost-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization.\n3. Patients with palpable splenomegaly at baseline of momelotinib treatment.\n4. Informed consent signed, if applicable.\n\nExclusion Criteria:\n\n1. Diagnosis of MPN, unclassifiable, myelodysplastic\u002Fmyeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.\n2. Accelerated\u002Fblast phase of MF.\n3. Patients with platelets \\\u003C20 x10(9)\u002FL at baseline of MMB treatment.\n4. Patients JAK inhibitors-exposed for other diseases apart from MF.",{"count":151,"type":21},93,"Observational study aimed at evaluating the use of momelotinib in patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) in a real-world setting.",[154],"Myelofibrosis (MF)",[156,157,131,158,159],"Myelofibrosis","momelotinib","post polycythemia","post essential thrombocythemia","2025-11-18",{"date":162,"type":31},"2025-11-25",{"date":164,"type":21},"2026-01-02",{"date":166,"type":21},"2028-04-02",{"name":37,"class":38},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":39},"100587814","observational-study-on-the-combination-of-selinexor-with-bortezomib-and-dexamethasone-for-the-treatment-of-mm-patients-100587814","NCT06933277","Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients","Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients","Inclusion Criteria:\n\n* Age equal to or greater than 18 years old at the time of SVd initiation\n* Signed informed consent (if applicable).\n* Diagnosis of symptomatic MM, as defined by the International Myeloma Working Group (IMWG) criteria.\n* Relapse after one to three lines of therapy.\n* Treatment with SVd, (i.e., having already received at least one dose) at the time the combination has entered clinical practice in Italy (AIFA authorization)\n* Prior treatment with and refractoriness to lenalidomide.\n\nExclusion Criteria:\n\n\\- Previous exposure to selinexor.",{"count":176,"type":21},159,"This is an observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.\n\nA minimum of 159 patients is required. Overall study duration is estimated in 36 months.",[179],"Multiple Myeloma",[181,182,183],"selinexor","bortezomib","dexamethasone","2025-09-03",{"date":186,"type":31},"2025-09-10",{"date":188,"type":31},"2025-08-29",{"date":190,"type":21},"2028-08",{"name":37,"class":38},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100605113","identification-of-bcrabl1-mutations-by-digital-pcr-in-cml-100605113","NCT07158294","Identification of BCR::ABL1 Mutations by Digital PCR in CML","Digital PCR for Deep Sensitivity BCR::ABL1 Mutation Screening in CML","DiP-in-CML","Inclusion Criteria:\n\n* molecularly confirmed diagnosis of BCR::ABL1+ CML;\n* positivity for either e13a2 or e14a2 transcript;\n* age ≥18 years;\n* chronic phase;\n* on therapy with imatinib or 2 GTKIs (dasatinib, nilotinib and bosutinib);\n* candidate to TKI switch because of resistance according to the ELN recommendations OR with a confirmed warning response to 2GTKI therapy according to the ELN recommendations;\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n\nExclusion Criteria:\n\n* blastic phase;\n* Previous allogeneic transplant or candidate to allogeneic transplant;\n* on treatment with ponatinib or asciminib, investigational TKIs or non-TKI-therapy;\n* switch performed or planned due to intolerance and not to resistance.",{"count":201,"type":21},150,"INTERVENTIONAL",[204],"NA","The goal of this study is to asses the ability of digital PCR (ddPCR) to detect actionable mutations in adult CML patients with failure of TKI therapy. The main objective of the study is it aims to answer is to assess whether ddPCR is at least as effective as NGS in detecting actionable (2GTKI-resistant) mutations.\n\nTo accomplish this aim, samples of participants treated according to clinical practice, will be taken and analyzed for the presence of BCR::ABL1 KD mutations by ddPCR.",[207],"Chronic Myeloid Leukemia (CML)",[209,210,211],"Failure","Digital PCR","BCR:ABL1 mutation","2025-08-28",{"date":214,"type":31},"2025-09-05",{"date":216,"type":21},"2026-02-01",{"date":218,"type":21},"2029-04-01",{"name":37,"class":38},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100555529","observational-study-on-the-outcome-of-aml-patients-treated-with-new-drugs-in-real-life-boxtrial-100555529","NCT06513273","Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)","Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life","Box","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. AML diagnosis according to the ELN guidelines, excluding M3\n3. Signed Informed consent, if applicable\n4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:\n\n   * patients affected by FLT3-mutated AML treated with gilteritinib.\n   * patients affected by IDH-mutated AML treated with IDH inhibitors.\n   * patients affected by AML in maintenance therapy with oral azacytidine.\n   * patients affected by AML treated with glasdegib.\n   * patients affected by AML treated with gemtuzumab ozogamicin.\n   * other novel drugs or combination for the treatment of AML approved during the study period.\n\nExclusion Criteria:\n\nPatients included in interventional clinical trials.",{"count":229,"type":21},397,"This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.",[25,232,233],"AML, Adult","Acute Myeloid Leukemia, Adult","2025-08-08",{"date":236,"type":31},"2025-08-13",{"date":238,"type":31},"2025-07-11",{"date":240,"type":21},"2029-12",{"name":37,"class":38},2,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":263},"100566643","hrqol-and-financial-toxicity-in-patients-with-vexas-syndrome-100566643","NCT06657846","HRQoL and Financial Toxicity in Patients With VEXAS Syndrome","Health-Related Quality of Life and Financial Toxicity in Patients With VEXAS Syndrome: An Italian GIMEMA Study","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) with a confirmed diagnosis of VEXAS syndrome (UBA1 pathogenic mutation detected)\n* Written informed consent\n\nExclusion Criteria:\n\n* \\- Having any kind of psychiatric disorder or major cognitive dysfunction.\n* Not able to read and understand local language","99 Years",{"count":252,"type":21},100,"This multicenter cross-sectional observational study aims to describe health-related quality of life (HRQoL) and symptom profiles of patients with VEXAS syndrome.",[255],"VEXAS","2025-07-14",{"date":258,"type":31},"2025-07-15",{"date":260,"type":31},"2024-11-01",{"date":186,"type":21},{"name":37,"class":38},17,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":202,"phases":274,"briefSummary":276,"conditions":277,"keywords":281,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100547589","phase-2-pearl-study-potential-of-asciminib-in-the-early-treatment-of-cml-100547589","NCT06409936","PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","PEARL","Inclusion Criteria:\n\n* Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML\n* Age ≥ 18 years\n* Early chronic phase, less than 3 months from diagnosis\n* Evidence at the time of study entry of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 (b2a2 or b3a2), which are required for BCR::ABL1 international scale reporting\n* Prior treatment with any TKI for 30 days or less; prior treatment with hydroxyurea or anagrelide is allowed\n* ECOG performance status of 0, 1 or 2\n* Adequate end organ function as defined by Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3.0 x ULN Alanine transaminase (ALT) ≤ 3.0 x ULN Serum amylase ≤ ULN Serum lipase ≤ ULN Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related Creatinine clearance \\> 50 ml\u002Fmin using Cockcroft-Gault formula\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws prior to any study procedure\n* An effective form of contraception with their sexual partners from enrolment through 30 days after the end of treatment\n\nExclusion Criteria:\n\n* CML in blast phase (BP) or in second chronic phase after previous BP, according to WHO criteria\n* Previous treatment with TKIs for more than 30 days\n* Refusal or impossibility to give an informed consent\n* History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months), uncontrolled congestive heart failure, unstable angina (within last 6 months), clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection)\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* History of acute or chronic liver disease\n* History of other active malignancy within 2 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively\n* Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab \u002F anti HBc) will be performed at study entry\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)\n* Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 30 days after the end of treatment",{"count":273,"type":21},160,[275],"PHASE2","A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).\n\nAll patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.\n\nDuring the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.\n\nThe patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.",[278,279,280,52],"CML, Chronic Phase","Chronic Myeloid Leukemia, Chronic Phase","Chronic Myeloid Leukemia, BCR\u002FABL-Positive",[56,282],"nilotinib","2025-07-07",{"date":285,"type":31},"2025-07-08",{"date":287,"type":31},"2025-06-26",{"date":289,"type":21},"2032-06",{"name":37,"class":38},11,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":202,"phases":303,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},"100376667","phase-3-feasibility-of-allogeneic-stem-cell-transplantation-in-higher-risk-mds-acrobat-100376667","NCT04184505","Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)","Prospective Randomized Study on the Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-myelodysplastic Syndromes, Performed Upfront or Preceded by Azacitidine or Conventional Chemotherapy According to the BM-blast Proportion","ACROBAT","Inclusion Criteria:\n\n1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high\n2. Age 18-70 years\n3. Previously untreated for HR-MDS\n4. HSCT - eligible\n5. Life expectancy ≥3 months;\n6. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2\n\nExclusion Criteria:\n\n1. Acute myeloid leukaemia with \\>20% blasts in BM or peripheral blood (PB);\n2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);\n3. severe renal, cardiac, liver or lung impairment;\n4. pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine.\n5. HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis;\n6. clinically relevant neurological or psychiatric diseases;\n7. hypersensitivity (known or suspected) to AZA;\n8. prior Treatments:\n\n   1. prior investigational drugs (within 30 days);\n   2. radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;\n   3. growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;\n   4. androgenic hormones during the previous 14 days;\n   5. prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS (a previous treatment with Lenalidomide is admitted, provided that lenalidomide had been stopped at least 60 days before enrolment).","70 Years",{"count":302,"type":21},274,[304],"PHASE3","Open-label, randomized multicenter phase III non-inferiority study",[307],"High-risk MDS",[309,310,311],"MDS","Transplant","Azacitidine","2025-04-28",{"date":314,"type":31},"2025-04-29",{"date":316,"type":31},"2020-11-27",{"date":318,"type":21},"2026-03-01",{"name":37,"class":38},46,{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":202,"phases":331,"briefSummary":332,"conditions":333,"keywords":337,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100583766","phase-2-teclistamab-plus-autologous-lymphocyte-infusion-ali-for-the-treatment-of-rr-multiple-myeloma-100583766","NCT06880601","Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R\u002FR Multiple Myeloma","Teclistamab Plus Autologous Lymphocytes Infusion for the Treatment of Relapse\u002FRefractory Multiple Myeloma (TALIM)","TALIM","Inclusion Criteria:\n\n* • Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)\n\n  * Patient age is ≥ 18 years of age\n  * Patient has a Relapsed or refractory disease as defined below:\n\n    * Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria \\>60 days after cessation of treatment\n    * Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.\n  * Previous treatment with 1 or 2 lines of treatment (induction plus autologous stem cell transplant plus consolidation and maintenance has to be considered one single line)\n  * Previous triple exposure that included an IMID, a PI, and an anti-CD38 antibody (patients with no response or relapse after front line therapy with Dara-VTD or Dara-VRD are eligible)\n  * Progressive active symptomatic disease\n  * Patient has measurable disease as defined by any of the following:\n\n    * Serum M-protein level ≥0.5 g\u002FdL; or\n    * Urine M-protein level ≥200 mg\u002F24 hours; or\n    * Serum immunoglobulin free light chain ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n  * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n  * Able to adhere to the study visit schedule and all the other protocol procedures and requirements;\n  * Patient has the following laboratory parameters:\n\n    * Total lymphocytes count ≥ 0.3 x 109\u002FL\n    * Platelet count \\> 50 x 109\u002FL unless due to bone marrow involvement by MM\n    * Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MM\n    * Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MM\n    * Creatinine clearance ≥ 30 ml\u002Fmin\n  * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 2-7 days prior to C1D1\n  * Life expectancy ≥ 2 months\n  * Successful collection of at least 100 x 106\u002Fkg autologous lymphocytes before starting treatment with Te.\n  * Patient understands and voluntarily signs an informed consent form\n\nExclusion Criteria:\n\n* • Previous treatment with \\> 2 lines of therapy\n\n  * Patient has active central nervous system involvement with MM\n  * Received any prior BCMA-directed therapy\n  * Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:\n\n    * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less\n    * Investigational vaccine within 4 weeks\n    * Monoclonal antibody therapy within 21 days\n    * Cytotoxic therapy within 21 days\n    * PI therapy within 14 days\n    * IMiD agent therapy within 14 days\n    * Radiotherapy within 14 days or focal radiation within 7 days\n  * Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n  * Stem cell transplant:\n\n    * previous allogeneic stem cell transplant\n    * autologous stem cell transplant performed within 12 weeks\n  * Patients with plasma cell leukemia (presence of 5% or more plasma cells in conventional peripheral blood smear white blood cell differential count)\n  * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients\n  * Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM)\n  * Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy\n  * Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n    * Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS)\n    * Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n    * Non-invasive cervical cancer\n    * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted)\n    * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment)\n    * Other malignancy that is considered cured with minimal risk of recurrence in consultation with the treating physician\n  * Clinically relevant and active liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances\n  * Patient has any other concurrent severe and\u002For uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active\u002Fsymptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), active hemorrhage, psychiatric illness, active or uncontrolled infection that in the investigator opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form\n  * Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study.\n  * Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment\n  * Patient has a known history of HIV seropositivity\n  * Seropositive for hepatitis B: defined by a positive test for HbsAg. Participants with resolved infection (ie, participants who are HbsAg negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Participants with a known history of HBV infection must be screened using RT-PCR measurement of HBV DNA levels irrespective of serological results. Those who are RT-PCR positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT-PCR (see Appendix 12).\n  * Active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.",{"count":330,"type":21},52,[275],"The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI?\n\nParticipants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6",[334,335,336],"Multiple Myleoma","Multiple Myeloma in Relapse","Multiple Myeloma Refractory",[179,338,339,340,341],"Relapse","Refractoriness","Teclistamab","Autologous lymphocyte infusion","2025-03-31",{"date":344,"type":31},"2025-04-03",{"date":346,"type":21},"2025-11-01",{"date":348,"type":21},"2029-11-01",{"name":37,"class":38},{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":39},"100518249","real-world-mapping-antithrombotic-regimens-in-mm-patients-on-treatment-100518249","NCT06028087","Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment","Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)","Inclusion Criteria:\n\n1. Age equal to or greater than 18 years of age.\n2. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group\n3. First active treatment for MM started after recruitment in the study\n4. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients having had thrombosis within 6 months before diagnosis of MM\n2. Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)\n3. Ongoing first active treatment for MM initiated before the starting of the study.",{"count":358,"type":21},736,"The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).",[179,361],"Diagnosis","2025-03-12",{"date":364,"type":31},"2025-03-14",{"date":366,"type":21},"2025-03-10",{"date":368,"type":21},"2030-03",{"name":37,"class":38},{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":5},"100429118","study-on-the-diagnosis-and-management-of-cll-in-italy-by-gimema-100429118","NCT04867915","Study on the Diagnosis and Management of CLL in Italy by GIMEMA","Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)","Inclusion Criteria:\n\n1. Age ≥18 years at diagnosis\n2. One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)\n\n   1. Chronic lymphocytic leukemia (CLL)\n   2. Small lymphocytic lymphoma (SLL)\n   3. CLL-like monoclonal B-cell lymphocytosis (MBL)\n3. Retrospective cohort: CLL\u002FSLL\u002FMBL diagnosis between January 1st 2010 and August 31th 2021.\n4. Prospective cohort: CLL\u002FSLL\u002FMBL diagnosis between September 1st 2021 and September 1st, 2025.\n5. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws (if applicable)\n\nExclusion Criteria:\n\n* \\- -",{"count":378,"type":21},12500,"retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL.\n\nretrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021.\n\nprospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.",[381,382,383],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type",{"date":364,"type":31},{"date":386,"type":31},"2021-10-13",{"date":388,"type":21},"2026-10",{"name":37,"class":38},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":202,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":4},"100567421","phase-2-efficacy-of-gilteritinib-in-combination-with-flai-as-induction-therapy-of-flt3-positive-acute-myeloid-leukemia-100567421","NCT06667973","Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia","A Phase 2, Open-label, Multicentre Study Investigating Tolerability and Efficacy of Gilteritinib in Combination With Fludarabine, Cytarabine and Idarubicin (FLAI) as Induction Therapy of Newly Diagnosed Non-M3 FLT3-positive Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. The patient is ≥ 18 and ≤65 years old.\n2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2.\n3. The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:\n\n   1. Left ventricular ejection fraction (LVEF) ≥institutional lower limit of normal as measured by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiography (ECHO) within 21 days before start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).\n   2. ECG: QTcF≤450 male ≤480 female\n   3. Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of \\> 50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n   4. Bilirubin ≤3 times the upper limit of normal ULN mg\u002FdL except for Gilbert's condition\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)., except if due to leukemic involvement.\n4. Patient is positive at diagnosis for FLT3 activating mutation in bone marrow or whole blood.\n5. Diagnosis of untreated AML according to WHO 2016, non-APL\n6. If the patient is a woman of childbearing potential (WOCBP), she must have a negative serum or urine pregnancy test at screening within 1 week before treatment.\n7. The patient (male and female) agrees to use two acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 6 months after the end of treatment\n8. The patient has signed informed consent before initiation of any study-specific procedures or treatment.\n9. The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment\n\nExclusion Criteria:\n\n1. Patient was diagnosed as acute promyelocytic leukemia.\n2. Patient has BCR-ABL-positive leukemia or chronic myelogenous leukemia in blast crisis.\n3. Patient has clinically active central nervous system leukemia.\n4. Patient has been diagnosed with another malignancy, unless disease-free for at least 3 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, papillary thyroid carcinoma, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.\n5. Patient has had major surgery within 4 weeks prior to the first study dose.\n6. Patient has radiation therapy within 4 weeks prior to the first study dose.\n7. Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.\n8. Patient has an active uncontrolled infection.\n9. Patient has active human immunodeficiency virus infection.\n10. Patient has active hepatitis B or C or other active hepatic disorder. Chronic conditions previously cured or in active prophylaxis are allowed in the study\n11. Patient has infections, comorbidities or any disease, condition or alteration that per judgment of the investigator may be jeopardized by therapy\n12. Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000\u002Fmm3. HU and 6MP must be discontinued at the time of initiation of study medications.","65 Years",{"count":399,"type":21},80,[275],"The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients. The main question it aims to answer is:\n\nIs gilteritinib in combination to chemotherapy able to improve the complete remission rate of FLT3-positive AML?\n\nParticipants will receive up to 2 induction cycles with gilteritinib in combination with FLAI (fludarabine, cytarabine, idarubicine) and up to 3 consolidation cycles with gilteritinib and high-dose cytarabine.",[25,403,404,361],"FLT3 Gene Mutation","Adult AML",{"date":362,"type":31},{"date":407,"type":21},"2025-06",{"date":409,"type":21},"2030-06",{"name":37,"class":38},{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":202,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},"100375438","phase-3-gemtuzumab-chemotherapy-mrd-levels-adult-untreated-de-novo-fav-interm-risk-aml-100375438","NCT04168502","Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML","Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML","Inclusion Criteria:\n\n1. Signed written informed consent according to ICH\u002FEU\u002FGCP and national\u002Flocal laws\n2. Patients aged between 18 and 60 years\n3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy\n4. Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration)\n5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD\u002FTKD positive AML)\n6. WHO performance status 0-3\n7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement\n8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram\n9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection\n10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.\n\nExclusion Criteria:\n\n1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy\n2. Acute promyelocytic leukemia\n3. Blast crisis of chronic myeloid leukemia\n4. FLT3-ITD\u002FTKD positive AML\n5. AML supervening after other myeloproliferative disease\n6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration\n7. Therapy-related AML\n8. Other active or progressive malignant diseases.\n9. Inadequate renal or liver function (metabolic abnormalities \\> 2-2.5 times the normal upper limit)\n10. Severe heart failure requiring diuretics\n11. Ejection fraction \\\u003C 50%\n12. Uncontrolled infections\n13. Severe concomitant neurological or psychiatric diseases\n14. Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.","60 Years",{"count":420,"type":21},414,[304],"MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable\u002Fintermediate-risk AML. Post-consolidation assessment of MRD.",[25],[425,426,427,428,25],"De-novo","Favorable risk","Intermediate risk","Gemtuzumab ozogamicin","2024-11-07",{"date":431,"type":31},"2024-11-08",{"date":433,"type":31},"2020-09-24",{"date":435,"type":21},"2027-04",{"name":37,"class":38},48,{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":202,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100407625","molecular-mechanisms-of-disease-relapse-after-allogenic-stem-cell-transplantation-in-mds-patients-100407625","NCT04587856","Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients","Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Diagnosis of MDS according to 2016 WHO criteria\n* Aged 18y or older\n* Patients who will receive allogeneic stem cell transplantation (HSCT)\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nExclusion Criteria:\n\n* Second HSCT procedure.",{"count":446,"type":21},38,[204],"This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.",[450],"Myelodysplastic Syndromes","2024-10-21",{"date":453,"type":31},"2024-10-22",{"date":455,"type":31},"2021-02-12",{"date":457,"type":21},"2025-03",{"name":37,"class":38},7,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":4},"100551956","observational-study-on-the-outcome-of-patients-with-itp-who-underwent-splenectomy-after-2010-100551956","NCT06466824","Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010","Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Patients with primary ITP according to international criteria \\[2\\], who underwent to splenectomy from 01\u002F01\u002F2010 to 12\u002F31\u002F2022.\n* Obtaining Informed Consent.\n\nExclusion Criteria:\n\n* none",{"count":468,"type":21},157,"Retrospective data collection on ITP patients who underwent splenectomy from 01\u002F01\u002F2010 to 12\u002F31\u002F2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.",[471],"Primary Immune Thrombocytopenia",[473],"splenectomy","2024-06-14",{"date":476,"type":31},"2024-06-20",{"date":478,"type":21},"2024-09",{"date":457,"type":21},{"name":37,"class":38},{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":202,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100492605","biologic-characterization-of-patients-with-itp-100492605","NCT05694325","Biologic Characterization of Patients With ITP","Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2.\n2. Previously untreated patients. Patients who have already started first-line therapy because of life-threatening bleeding are admitted to the study if samples are collected within 24 hours of starting treatment. In such cases, as first-line treatment steroids and platelet transfusions would be preferable over high-dose IVIg. Treatment received before the collection of samples will be carefully documented.\n3. Age ≥ 18 years\n4. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n\nExclusion Criteria:\n\n1\\. Secondary ITP. Patients with ANA positivity without a diagnosis of SLE are admitted to the study. As far as patients with ITP and antiphospholipid antibodies positivity, those with triple positivity (anti-beta2glicoprotein antibodies, anti-cardiolipin antibodies, lupus anticoagulans positivity) are excluded.",{"count":489,"type":21},200,[204],"This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.",[493],"Immune Thrombocytopenia","2024-05-20",{"date":496,"type":31},"2024-05-21",{"date":498,"type":31},"2023-11-27",{"date":500,"type":21},"2026-11",{"name":37,"class":38},5,{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":202,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":39},"100544065","biological-and-clinical-efficacy-of-shingrix-in-patients-with-cll-100544065","NCT06364033","Biological and Clinical Efficacy of Shingrix in Patients With CLL","Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n* Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines. Patients must belong to one of the following subgroups:\n\n  * Group A: Patients with MBL or previously untreated early-phase CLL\u002FSLL (Binet stage A or RAI stage 0), with no clear signs of disease progression;\n  * Group B: Patients with active or symptomatic disease according to IWCLL guidelines or with advanced Binet or Rai stages receiving both the first and second vaccine doses before treatment initiation;\n  * Group C: Patients with CLL\u002FSLL receiving targeted drugs (i.e. ibrutinib\u002Facalabrutinib-based treatment or venetoclax-based treatment) for at least 6 months prior to the administration of the first vaccine dose.\n* Age 18 years or older\n* Eligible to receive Shingrix according to clinical indication and free of charge through the Italian National Health System\n* Life expectancy \\>6 months\n* No active, symptomatic herpes zoster infection or varicella-zoster virus reactivation within 12 months prior to vaccination\n* No prior exposure to Shingrix\n* Able and willing to provide written informed consent and to comply with the study protocol procedures\n\nExclusion Criteria:\n\n* Female patients who are currently in pregnancy or are willing to be pregnant\n* Any uncontrolled active systemic infection\n* Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination\n* Concomitant use of radiotherapy or chemotherapy\n* Hereditary or acquired immunodeficiency syndrome unrelated to CLL\n* Chronic use of immunosuppressive medications given for indications that are not CLL-related",{"count":511,"type":21},312,[204],"This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.",[381,382,515,516],"CLL-like MBL","Varicella-zoster Virus Reactivation","2024-05-08",{"date":519,"type":31},"2024-05-09",{"date":521,"type":21},"2024-08",{"date":523,"type":21},"2028-10",{"name":37,"class":38},{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":202,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":4},"100523066","kinetics-and-impact-on-survival-of-mrd-in-aml-patients-receiving-azacitidine-and-venetoclax-100523066","NCT06090786","Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax","A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax","Inclusion Criteria:\n\n* Subject must be ≥ 18 years of age\n* Subject has diagnosis of AML according to WHO 2016\n* Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)\n* Subject is planned to receive front-line therapy with Azacitidine and Venetoclax\n* Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice\n* Subject must have assessable MRD by flow cytometry at screening BM evaluation\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nExclusion Criteria:\n\n* Diagnosis of BCR::ABL1-positive AML\n* Diagnosis of APL\n* AML with CNS involvement.\n* AML with extra-medullary localizations\n* Patients' unwillingness or inability to comply with the protocol requirements.",{"count":533,"type":21},225,[204],"The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.\n\nThe main questions it aims to answer are:\n\n1. kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques\n2. impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.",[232,537],"Minimal Residual Disease",[539,311,540,541],"Venetoclax","AML","Minimal rsidual disease","2024-04-09",{"date":544,"type":31},"2024-04-10",{"date":546,"type":21},"2024-07",{"date":548,"type":21},"2027-07",{"name":37,"class":38},{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":202,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":39},"100503756","novel-approaches-to-target-mecomevi1-in-aml-100503756","NCT05839392","Novel Approaches to Target MECOM\u002FEVI1 in AML","Novel Approaches to Target MECOM\u002FEVI1 in Acute Myeloid Leukemia","Inclusion Criteria:\n\n* AML with MECOM or atypical 3q26 rearrangements.\n* Age ≥18.\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n\nExclusion Criteria:\n\n* None",{"count":5,"type":21},[204],"This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.",[232],"2023-12-22",{"date":563,"type":31},"2023-12-29",{"date":565,"type":31},"2023-12-13",{"date":567,"type":21},"2026-12",{"name":37,"class":38},{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":202,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":589,"locationsCount":590},"100492604","phase-2-ibrutinib-for-the-treatment-of-aiha-in-patients-with-cllsll-or-cll-like-mbl-100492604","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.",{"count":577,"type":21},45,[275],"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.",[581,381,382,582],"Autoimmune Hemolytic Anemia","Monoclonal B-Cell Lymphocytosis CLL-Type","2023-11-28",{"date":585,"type":31},"2023-12-01",{"date":587,"type":31},"2023-11-24",{"date":500,"type":21},{"name":37,"class":38},3,""]