[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ph-acute-lymphoblastic-leukemia-phall\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ph-acute-lymphoblastic-leukemia-phall":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29,30],"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",[32,33,34,35,36,37,38,39],"Ph+ B-ALL","CML-BP","Asciminib","Asciminib add-on","allogeneic HSCT maintenance","Asciminib with Imatinib","Asciminib with Nilotinib","Asciminib with Dasatinib","NOT_YET_RECRUITING","2026-03-20",{"date":43,"type":44},"2026-03-25","ACTUAL",{"date":46,"type":21},"2026-03-30",{"date":48,"type":21},"2037-12-31",{"name":50,"class":51},"The University of Hong Kong","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100566726","phase-2-olverembatinib-as-maintenance-therapy-or-preemptive-therapy-after-allo-hsct-in-phall-100566726","NCT06658925","Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL","The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* ( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR \u002F ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.\n\n( 2 ) Age older than or equal to 18 years old ( 3 ) Informed consent can be signed by themselves. ( 4 ) Adequate organ function must be met : renal function and liver function are as follows : serum creatinine is 2 times lower than the normal upper limit, AST, ALT and ALP are lower than the normal upper limit of 3 times, and total bilirubin is lower than the normal upper limit of 3 times ( if the liver GVHD is clearly diagnosed, less than or equal to 5 × ULN ) ).\n\n( 5 ) HIV negative, HBV and HCV negative. ( 6 ) The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.\n\n( 7 ) Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.\n\nExclusion Criteria:\n\n* ( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.\n\n( 2 ) Severe cardiovascular diseases ( including myocardial infarction, unstable angina pectoris, severe arrhythmia and congestive heart failure, etc. ) occurred during the previous use of the third generations of TKI treatment.\n\n( 3 ) Uncontrolled infection at the time of enrollment ; severe complications of mechanical ventilation or hemodynamic instability ; those who had undergone autologous or allogeneic stem cell transplantation; ( 4 ) The serological reaction of known HIV or active hepatitis C virus is positive ; ( 5 ) suffering from mental illness or other illness and can not cooperate with the research treatment and monitoring requirements ; ( 6 ) being unable or unwilling to sign the consent ; ( 7 ) pregnant or lactating women ; ( 8 ) Patients with other special conditions who were assessed as unqualified by the researchers.",{"count":61,"type":21},50,[24],"This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil \\> 0.5 × 10 \\^ 9 \u002F L, platelet \\> 50 × 10 \\^ 9 \u002F L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).",[27,65,66],"HSCT","Tyrosine Kinase Inhibitor","2024-10-23",{"date":69,"type":44},"2024-10-26",{"date":71,"type":21},"2024-11-01",{"date":73,"type":21},"2027-08-31",{"name":75,"class":51},"Institute of Hematology & Blood Diseases Hospital, China"]