[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529586":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":75,"centralContacts":80,"locations":10,"responsibleParty":89,"collaborators":10,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":10,"enrollmentInfo":101,"targetDuration":10,"studyType":104,"phases":10,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":114,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":10},{"fullName":5,"class":6},"PETHEMA Foundation","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Complete molecular response and low risk genetics",null,"Patients in Complete Remission and Complete Molecular Response at end Induction therapy will receive consolidation with imatinib (or dasatinib if intolerance) and chemotherapy, unless they show the IKZF1plus genotype, which will imply switch to the not complete molecular response or high-risk genetics (IKZ1plus) group.",[13,14,15,16,17,18],"Drug: Vincristine","Drug: Dexamethasone","Drug: Imatinib","Drug: Cytarabine","Drug: Mercaptopurine","Drug: Methotrexate",{"label":20,"type":10,"description":21,"interventionNames":22},"Not complete molecular response or high-risk genetics (IKZF1plus)","Patients in Complete Remission and without Complete Molecular Response at the end of Induction therapy or showing the IKZF1plus genotype, will receive consolidation treatment with ponatinib and chemotherapy followed by allogeneic stem cell transplantation and maintenance therapy.",[13,14,15,16,17,18,23,24,25,26,27],"Drug: Ponatinib","Procedure: allogeneic stem cell transplantation","Procedure: Total body irradiation","Drug: Cyclophosphamide","Drug: Fludarabine",[29,34,38,42,46,50,54,58,63,67,71],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"DRUG","Vincristine","dose 1.5 mg\u002Fm2 at days 1, 8, 15 and 22",[9,20],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Dexamethasone","40 mg on days 1-2, 8-9,15-16 and 22-23",[9,20],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Imatinib","600 mg per day from 1 to up to 5 years",[9,20],{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Cytarabine","1000 mg\u002Fm2\u002F on days 1, 3 and 5 of consolidation with 2h infusion",[9,20],{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Mercaptopurine","50 mg\u002Fm2 on days 1 to 28 of maintenance",[9,20],{"type":30,"name":51,"description":52,"armGroupLabels":53,"otherNames":10},"Methotrexate","1000 mg\u002Fm2 on day 1 of consolidation with 24h infusion; and 20 mg\u002Fm2 on days 1, 8, 15 and 22 of maintenance",[9,20],{"type":30,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"Ponatinib","15 mg per day from consolidation start up to 5 years",[20],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":10},"PROCEDURE","allogeneic stem cell transplantation","Allogeneic stem cell transplantation from hematpoietic stem cells progenitors of familiar or not familiar origin. Cord blood transplantation can also be done.",[20],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":10},"Total body irradiation","Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)",[20],{"type":30,"name":68,"description":69,"armGroupLabels":70,"otherNames":10},"Cyclophosphamide","60 mg\u002Fkg on days -6 and -5 before alloSCT",[20],{"type":30,"name":72,"description":73,"armGroupLabels":74,"otherNames":10},"Fludarabine","30 mg\u002Fm2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)",[20],[76],{"name":77,"affiliation":78,"role":79},"Josep M Ribera Santasusana, MD","Institut Catala d'Oncologia-Hospital Universitari Germans Trias i Pujol","PRINCIPAL_INVESTIGATOR",[81,85],{"name":77,"role":82,"phone":83,"phoneExt":10,"email":84},"CONTACT","0034934978387","jribera@iconcologia.net",{"name":86,"role":82,"phone":87,"phoneExt":10,"email":88},"Anna Torrent, MD","0034934978987","atorrent@iconcologia.net",{"type":90,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100529586","treatment-protocol-for-newky-diagnosed-adult-ph-positive-all-100529586",false,"NCT06175702","Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL","Treatment Protocol for Newky Diagnosed Adult Ph-Chromosome Positive (BCR::ABL1) Acute Lymphoblastic Leukemia (LALPh2022)","LALPh2022","Inclusion Criteria:\n\n1. Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.\n2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).\n3. Performance status 0-2; patients with performance status\\>2 attributable to ALL can be included.\n4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \\\u003C2 mg\u002Fdl or creatinine clearance \\> 30 ml\u002Fmin (except altered renal function attributable to ALL); normal heart function: EF ventricular \\> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.\n\nExclusion Criteria:\n\n1. Any other subtype of ALL.\n2. Patients with chronic liver disease.\n3. Patients with chronic respiratory failure.\n4. Renal failure not due to ALL.\n5. Lipase and amylase\\>1.5× ULN.\n6. Patients with positive HIV serology.\n7. Serious neurological alterations not due to ALL.\n8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.\n9. Pregnant or breastfeeding women.\n10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \\>450 mg\u002FdL.","ALL","18 Years",{"count":102,"type":103},150,"ESTIMATED","OBSERVATIONAL","The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI).\n\nEfficay refers to the rate of Complete Molecular Response (BCR::ABL1\u002FABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections.\n\nLow-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase.\n\nConsolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.",[107,108,109],"Lymphoblastic Leukemia","Philadelphia-Positive ALL","Adult ALL",[111,112,113],"Acute Lymphoblastic Leukemia","Philadelphia (BCR::ABL1) positive","Adults","NOT_YET_RECRUITING","2023-12-15",{"date":117,"type":118},"2023-12-19","ACTUAL",{"date":120,"type":103},"2023-12-25",{"date":122,"type":103},"2030-12-25",{"name":5,"class":6}]