[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-all-philadelphia-chromosome-positive-ph\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-all-philadelphia-chromosome-positive-ph":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100616116","phase-2-subcutaneous-blinatumomab-plus-ponatinib-for-bcr-abl-b-all-100616116",false,"NCT07301424","Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL","Phase II Study of Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL Positive B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Ph positive \\[either t(9;22) and\u002For BCR-ABL1 positive\\] ALL, CD19 positive\n2. Age ≥18 years at time of informed consent\n3. No prior induction treatment for ALL. A brief corticosteroid pre-phase (\\\u003C 1 week), or hydroxyurea for cytoreduction or symptom control is permitted.\n\n3\\. Greater than or equal to 5% blasts in the BM.\n\n4\\. Performance status ≤2 (ECOG Scale, see Appendix IV)\n\n5\\. Adequate organ function: 5.1.5.1 Hepatic:\n\nAdequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\nTotal serum bilirubin less than 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome or Meulengracht disease Alanine aminotransferase (ALT) less than 3 x ULN Aspartate aminotransferase (AST) less than 3 x ULN 5.1.5.2 Pancreatic:\n\n* Serum lipase less than 2 x ULN 5.1.5.3 Renal:\n* Estimated Creatinine clearance ≥ 40 mL\u002Fmin 5.1.5.4 Cardiac:\n* Left ventricular ejection fraction \\> 40%\n\nExclusion Criteria:\n\n1. Uncontrolled infection\n2. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus\n3. Presence of cardiovascular disease of clinical relevance within the past 3 months. This includes:\n\n   5.2.3.1 Unstable angina 5.2.3.2 Myocardial infarction 5.2.3.3 Transient ischemic attack or stroke 5.2.3.4 Peripheral vascular infarction, claudication and\u002For revascularization 5.2.3.5 Symptomatic congestive heart failure 5.2.3.6 Clinically significant significant atrial\u002Fventricular tachyarrhythmias 5.2.3.7 Venous thromboembolic event requiring systemic anticoagulation\n\n   Please consult the sponsor if there are specific concerns outside of these criteria\n4. Uncontrolled hypertension\n5. History or presence of clinically relevant CNS pathology or event.\n\n   This may include, for example:\n\n   epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis.\n\n   Before excluding a potential subject, please consult the sponsor.\n6. Any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.\n7. History of malignancy other than ALL within 3 years prior to start of protocol-specified therapy except for:\n\n   * malignancy treated with curative intent and with no known active disease present for 3 years before enrollment, and felt to be at low risk for recurrence by the treating physician\n   * adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   * adequately treated cervical carcinoma in situ without evidence of disease\n   * adequately treated breast ductal carcinoma in situ without evidence of disease\n   * prostatic intraepithelial neoplasia without evidence of prostate cancer\n8. Prior hematologic malignancy and\u002For alloSCT; this includes known CML\n9. Concurrent or prior (within 30 days) treatment with another investigational agent or study drug\n10. Female subject is pregnant or breastfeeding or planning to become pregnant breastfeed during treatment, and for an additional 4 months after the last dose of protocol-specified therapy\n11. Inability to swallow or absorb tablets\n12. Subject considered unsuitable for study for any other reason in the physician's best judgement. Before excluding a potential subject, please consult the sponsor.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","B-cell acute lymphoblastic leukemia (B-ALL) is an aggressive blood cancer; about 30% of B-ALL cases in adults have a mutation called BCR-ABL that drives the disease.\n\nBlinatumomab is an antibody drug that targets B-ALL cells and helps the immune system to kill them. It is usually given intravenously, but a newer formulation can be given under the skin. Ponatinib is a drug, taken by mouth, that targets and kills leukemia cells that have the BCR-ABL mutation.\n\nThe goal of this clinical trial is to test the effectiveness of treating patients with BCR-ABL positive B-ALL with blinatumomab given subcutaneously (under the skin) combined with ponatinib tablets. The study will also evaluate what side effects occur using this combination.\n\nParticipants will first receive ponatinib tablets for 70 days, along with prednisone for the first month. This will be followed by blinatumomab injections 3 times per week for 4 weeks, repeated for 5 treatment cycles, along with ponatinib. Participants will then continue ponatinib tablets alone for 5 years from the start of treatment.\n\nDuring treatment, participants will undergo regular blood and bone marrow tests to see how well the treatment is working, and to check for side effects. The effect of this treatments on their quality of life will also be evaluated.",[26,27],"Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)","BCR-ABL Positive Acute Lymphoblastic Leukemia",[29,30,31,32,33],"Blinatumomab","Ponatinib","BiTE antibody","Acute lymphoblastic leukemia","BCR-ABL positive acute lymphoblastic leukemia","NOT_YET_RECRUITING","2026-05-04",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":20},"2026-07-01",{"date":42,"type":20},"2031-12",{"name":44,"class":45},"University of Alberta","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":17,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100604632","phase-3-newly-diagnosed-pediatric-ph-positive-b-all-protocol-100604632","NCT07152041","Newly-diagnosed Pediatric Ph-positive B-ALL Protocol","A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project","CAMS-Ph+ B-ALL","Inclusion Criteria:\n\nMust meet all items below:\n\n1. Age older than 1 month to younger 18 years.\n2. Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.\n3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.\n\nExclusion Criteria:\n\nShould be excluded if had any item below:\n\n1. ALL evolved from CML.\n2. Known underlying congenital immunodeficiency or metabolic disease.\n3. Congenital heart disease with cardiac insufficiency.\n4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.\n5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.\n6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).\n7. Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \\> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression).\n8. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.","1 Month",{"count":57,"type":20},150,[59],"PHASE3","This prospective clinical trial evaluates the effectiveness and safety of \"chemotherapy-light\" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3\u002FCD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric\u002Fadolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol",[26,62],"Childhood Leukemia, Acute Lymphoblastic",[64,29,65],"olverembatinib","venetoclax","RECRUITING","2025-08-28",{"date":69,"type":38},"2025-09-03",{"date":71,"type":38},"2025-03-28",{"date":73,"type":20},"2030-06",{"name":75,"class":45},"Institute of Hematology & Blood Diseases Hospital, China",24]