[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ph-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ph-all":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100630860","chemotherapy-with-targeted-immunotherapy-for-newly-diagnosed-ph-all-100630860",false,"NCT07493161","Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL","Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study","Inclusion Criteria:\n\n* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).\n* Age ≥ 14 years.\n* ECOG performance status ≤ 2.\n* Adequate organ function: Total bilirubin \\\u003C1.5x ULN; AST\u002FALT ≤2.5x ULN; Serum creatinine \\\u003C2x ULN; Cardiac enzymes \\\u003C2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \\>45%.\n* Male and female patients of childbearing potential must agree to use effective contraception.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.\n* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).\n* Myocardial infarction within 12 months prior to enrollment; uncontrolled\u002Funstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.\n* Uncontrolled active severe infection.\n* Active psychiatric illness that may hinder treatment completion or informed consent.\n* Any other condition deemed unsuitable for the study by the investigator.","ALL","14 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.",[26],"Ph+ ALL","RECRUITING","2026-05-10",{"date":30,"type":31},"2026-05-13","ACTUAL",{"date":33,"type":31},"2026-04-10",{"date":35,"type":20},"2030-03-30",{"name":37,"class":38},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100520042","phase-3-a-study-of-olverembatinib-in-patients-with-newly-diagnosed-ph-all-polaris-1-100520042","NCT06051409","A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)","A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL","Inclusion Criteria:\n\n1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)\n2. Expected survival of at least 3 months\n3. ECOG ≤ 2\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. A history of chronic myeloid leukemia (CML)\n2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly\n3. Previous or current clinical CNS diseases\n4. Autoimmune diseases that may involve the CNS\n5. Use of therapeutic doses of anticoagulants and\u002For antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed\n6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug\n7. Uncontrolled heart diseases\n8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism\n9. Use of prohibited drugs\n10. Disease or medical condition that is unstable or may affect its safety or compliance with the study\n11. Use of medications known to cause prolonged QT interval\n12. Active infections requiring systemic treatment\n13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer\n14. Contraindications to the use of glucocorticoids\n15. Bleeding disorders unrelated to ALL\n16. Plan to undergo major surgery\n17. Allergy to drug ingredients, excipients, or their analogues in the study\n18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period\n19. Other malignant tumors within 2 years\n20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study","18 Years",{"count":49,"type":20},350,[51],"PHASE3","A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).",[26,54],"Leukemia, Lymphoblastic, Acute, Philadelphia-Positive",[26,56,57,58],"Olverembatinib","Acute lymphoblastic leukemia","Bcr-Abl Tyrosine Kinase","2026-04-24",{"date":61,"type":31},"2026-04-30",{"date":63,"type":31},"2023-08-31",{"date":65,"type":20},"2029-06-30",{"name":67,"class":68},"Ascentage Pharma Group Inc.","INDUSTRY",90,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100627042","phase-2-efficacy-and-safety-of-olverembatinib-plus-inotuzumab-ozogamicin-as-first-line-consolidation-therapy-followed-by-hsct-in-ph-all-100627042","NCT07443488","Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL","A Study on the Efficacy and Safety of Olverembatinib Combined With Inotuzumab Ozogamicin as First-Line Consolidation Therapy Bridging to Hematopoietic Stem Cell Transplantation in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* (1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.\n* (2) Age greater than or equal to 18 years.\n* (3) Able to provide informed consent independently.\n* (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL\u002Fmin; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) \\> 60%, pulmonary artery systolic pressure ≤ 50 mmHg.\n* (5) Negative for HIV, HBV, and HCV.\n* (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* (7) Informed consent must be signed before the start of study procedures. For subjects aged 18 years and above, informed consent should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is detrimental to treatment, the legal guardian or immediate family member may sign the informed consent.\n\nExclusion Criteria:\n\n* (1) Mixed lineage leukemia;\n* (2) Involvement of the central nervous system or extramedullary infiltration;\n* (3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study;\n* (4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3);\n* (5) History of clinically significant liver diseases, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe\u002Funcontrolled liver diseases, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis;\n* (6) Active cardiac disease, defined as one or more of the following: history of any cardiac or vascular disease; history of uncontrolled or symptomatic angina; myocardial infarction within 6 months prior to study enrollment; history of arrhythmias requiring medication or with severe clinical symptoms; uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] Class 2); ejection fraction below the lower limit of normal; pulmonary artery systolic pressure \\> 50 mmHg on echocardiography; or clinical symptoms related to pulmonary hypertension;\n* (7) History of severe cardiovascular events (including myocardial infarction, unstable angina, severe arrhythmias, congestive heart failure, etc.) during previous tyrosine kinase inhibitor (TKI) treatment for chronic myeloid leukemia (CML);\n* (8) Abnormal coagulation function;\n* (9) Known seropositivity for HIV or active hepatitis C virus;\n* (10) Patients with psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements;\n* (11) Inability or unwillingness to sign the consent form;\n* (12) Pregnant or lactating women;\n* (13) Patients assessed by the investigator as ineligible due to other special circumstances.",{"count":78,"type":20},20,[80],"PHASE2","To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.",[83,26],"HSCT","NOT_YET_RECRUITING","2026-02-27",{"date":87,"type":31},"2026-03-02",{"date":89,"type":20},"2026-03-14",{"date":91,"type":20},"2027-10-31",{"name":37,"class":38}]