[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630879":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":77,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":27,"enrollmentInfo":93,"targetDuration":27,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":113,"whyStopped":27,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm (ASC + TKIs)","EXPERIMENTAL","Asciminib (ASC) add-on with a 2 years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib \u002F Dasatinib \u002F Nilotinib.\n\nTKI will be added from 5th week onwards after.",[13,14,15,16],"Drug: Asciminib add-on","Drug: Imatinib","Drug: Dasatinib","Drug: Nilotinib",{"label":18,"type":6,"description":19,"interventionNames":20},"Control Arm (TKIs only)","2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib \u002F Dasatinib \u002F Nilotinib",[14,15,16],[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Asciminib add-on","Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Imatinib","Imatinib 300mg QD (Ramp-up from 100mg QD for first 4-weeks, 200mg QD for following 4-weeks then 300mg QD for subsequent weeks), Maximum 2-years treatment",[18,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Dasatinib","Dasatinib 50mg QD (Ramp-up from 20mg QD for first 4-weeks, 40mg QD for following 4-weeks then 50mg QD for subsequent weeks), Maximum 2-years treatment",[18,9],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Nilotinib","Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment",[18,9],[41],{"name":42,"affiliation":43,"role":44},"Yok-Lam KWONG, MBBS, MD, FRCP(UK), FRCPath(UK","The University of Hong Kong & Queen Mary Hospital","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":27,"email":50},"Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK)","CONTACT","+852 2255 3975","lmk381@ha.org.hk",{"name":52,"role":48,"phone":49,"phoneExt":27,"email":53},"Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK)","simpyj@ha.org.hk",[55],{"facility":5,"status":27,"city":56,"state":27,"zip":27,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Hong Kong","HK",{"type":59,"coordinates":60},"Point",[61,62],114.17469,22.27832,{"lat":62,"lon":61},[65,69,71,73],{"name":66,"role":48,"phone":67,"phoneExt":27,"email":68},"Rebecca W.M. CHUNG","+852 2255 4155","rebeccachung@hku.hk",{"name":70,"role":44,"phone":27,"phoneExt":27,"email":27},"Yok-Lam Kwong, MBBS, MD, FRCP(UK), FRCPath(UK",{"name":47,"role":72,"phone":27,"phoneExt":27,"email":27},"SUB_INVESTIGATOR",{"name":52,"role":72,"phone":27,"phoneExt":27,"email":27},{"type":44,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Professor Yok-lam Kwong","Professor",[78,81],{"name":79,"class":80},"Novartis","INDUSTRY",{"name":82,"class":6},"Queen Mary Hospital, Hong Kong","100630879","phase-2-asciminib--standard-of-care-integration-in-maintenance-therapy-for-post-allogeneic-stem-cell-transplant-allo-hsct-of-patient-with-ph-b-all-or-blastic-transformed-cml-100630879",false,"NCT07493408","Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML","Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)","ASIM-POST Ph+","Inclusion Criteria:\n\n1. The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an informed consent form (ICF) indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.\n2. Age ≥ 18 years\n3. Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT\n4. Patients must have received TKI therapy in induction\u002Fconsolidation therapy\n5. Absolute neutrophil count ≥ 1.0 × 109\u002FL\n6. Platelet count ≥ 50 × 109\u002FL\n\nExclusion Criteria:\n\n1. Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2\n3. Uncontrolled hypertension\n4. Corrected QT interval (QTc) \\> 460 milliseconds for women or \\> 450 milliseconds for men\n5. Amylase and lipase values \\> 3 × upper limit of normal\n6. Patients refused standard TKI maintenance post-HSCT\n7. Unable to comply with study requirements\n8. Patients taking ponatinib as choice of TKI\n9. Patients with documented T315I mutation","ALL","18 Years",{"count":94,"type":95},45,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).\n\nThe main questions it aims to answer are:\n\nWould Ascminib add-on maintenance therapyimprove Morphological relapse-free survival rate? Would Ascminib add-on maintenance therapy improve Molecular relapse-free survival and Overall survival ? Any toxicity or intolerable events during Ascminib add-on maintenance therapy?\n\nResearchers will compare Study arm (Ascminib plus tyrosine-kinase inhibitors \\[TKIs\\]) and Control arm (TKIs only) to see if Ascminib add-on maintenance therapy would provide better relapse-free survival (RFS) with optimal tolerability.\n\nParticipants will\n\n* Enrolled and Randomized into either Study arm or Control arm\n* Take Ascminib plus selected TKI or selected TKI only according to schedule\n* Visit the clinic once every 2-4 weeks for checkups and tests\n* Record and Report any adverse event and graft-versus-host-disease (GvHD) development",[101,102,103,104],"Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)","Blastic Transformation of Chronic Myeloid Leukemia","Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)","Haematopoietic Stem Cell Transplant, Allogeneic",[106,107,108,24,109,110,111,112],"Ph+ B-ALL","CML-BP","Asciminib","allogeneic HSCT maintenance","Asciminib with Imatinib","Asciminib with Nilotinib","Asciminib with Dasatinib","NOT_YET_RECRUITING","2026-03-20",{"date":116,"type":117},"2026-03-25","ACTUAL",{"date":119,"type":95},"2026-03-30",{"date":121,"type":95},"2037-12-31",{"name":5,"class":6},1]