[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"philadelphia-positive-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:philadelphia-positive-all":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,86,113],{"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":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":49},"100538184","phase-1-a-study-of-19-28zil-18-in-people-with-acute-lymphoblastic-leukemia-all-100538184",false,"NCT06287528","A Study of 19-28z\u002FIL-18 in People With Acute Lymphoblastic Leukemia (ALL)","A Phase I Trial of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells That Constitutively Secrete Interleukin 18 (19-28z\u002FIL-18) in Patients With Relapsed or Refractory (R\u002FR) Acute Lymphoblastic Leukemia (ALL)","Inclusion Criteria:\n\n* Patients must have R\u002FR ALL meeting one of the following criteria:\n* For Philadelphia chromosome (Ph) negative B-ALL: Refractory or relapsed disease to at least 1 prior multiagent systemic chemotherapy regimen that included both induction and consolidation therapy\n* For Philadelphia chromosome (Ph) positive B-ALL: patients must have exhibited persistent or progressive disease following at least 1 prior second- or third-generation tyrosine kinase inhibitor\n* Signed informed consent form (ICF) prior to any study procedures\n* Age: The first 3 patients enrolled into the study will be ≥ 17 years of age at time of enrollment. If a DLT is observed, the additional 3 patients in this cohort will also be ≥ 17 years of age. Additional patients will be ≥12 years of age at time of enrollment.\n* Documentation of CD19 positivity on leukemia blasts if prior anti-CD19 treatment\n* History of prior allogeneic hematopoietic stem cell transplant (HSCT) is allowed if ≥3 months from time of enrollment and no evidence of acute or chronic graft versus host disease (GVHD) within 4 weeks prior to enrollment\n* Donor lymphocyte infusions (DLI) permitted if ≥4 weeks prior to leukapheresis\n* History of secondary CNS or meningeal involvement allowed if:\n\n  * cannot be the only site of disease\n  * absence of neurologic symptoms, such as: seizures, stroke-like deficits, altered mental status, aphasia, or psychosis\n* Adequate organ function at time of screening, including:\n\n  * ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)\n  * Serum creatinine \\\u003C2.0mg\u002F100mL\n  * SaO2 ≥92% on room air\n  * Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening\n* ECOG performance status 0-1 or Lansky performance status ≥ 60 for patients \\\u003C 16 years old\n* Prior CD19-targeted therapies (including CD19 CAR-T cell and CD19 bispecific T-cell engagers) are allowed including anti-CD19 CAR T therapy, as long as CD19 positivity is confirmed on most recent bone marrow, blood or tumor biopsy\n\nExclusion Criteria:\n\n* Concurrent active malignancy excluding: nonmelanoma skin cancer or localized solid tumor that has undergone definitive therapy and with low risk of recurrence, e.g., prostate, breast\n* Burkitt's leukemia or lymphoma or CML in lymphoid blast crisis\n* Radiologically detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5\u002FµL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* The following medications are excluded:\n\n  * Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.\n  * Chemotherapy: Systemic chemotherapy should be stopped one week prior to leukapheresis or starting CAR T cell infusion or lymphodepleting chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion.\n* History of class III-IV New York Heart Association (NYHA) heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac condition within 6 months of screening\n* Patients with history of significant autoimmune disease and\u002For inflammatory condition affecting the CNS are ineligible\n* Systemic treatment for GVHD within 4 weeks prior to enrollment\n* Patients with known severe autoimmune disease (e.g., Crohn's, rheumatoid arthritis, or lupus) that in the investigator's opinion has high likelihood of requiring systemic immune suppressive medications\n* Patients with HIV infection\n* Patients with active hepatitis B infection (as manifested by either detectable hepatitis B virus DNA by PCR and\u002For positivity for hepatitis B surface antigen)\n* Patients with active hepatitis C infection (as manifested by detectable hepatitis C virus RNA by PCR)\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection including COVID-19 at time of leukapheresis or at time of CAR T cell infusion.\n* Other uncontrolled medical or psychological conditions as well as social or logistical issues that may interfere with compliance with the protocol, as determined by the investigator\n* Treatment with live, attenuated vaccine \\\u003C4 weeks prior to leukapheresis\n* Pregnant or lactating\u002Fbreastfeeding women","ALL","17 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z\u002FIL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.",[26,27,28,29,30,31],"Philadelphia-Negative ALL","Philadelphia-Positive ALL","Relapsed ALL, Adult","Refractory Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia (ALL)","Refractory Acute Lymphoid Leukemia in Relapse",[26,27,33,34,28,29,30,31,35,36,37],"Philadelphia chromosome negative (Ph-negative) B-ALL","Philadelphia chromosome positive (Ph+ positive) B-ALL","19-28z\u002FIL-18","23-307","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-02-09",{"date":41,"type":42},"2026-02-10","ACTUAL",{"date":44,"type":42},"2024-02-23",{"date":46,"type":20},"2028-02-23",{"name":37,"class":48},"OTHER",7,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100533028","phase-2-a-single-arm-open-label-study-of-olverembatinib-cd3cd19-bispecific-t-cell-engager-and-chidamide-in-patients-with-newly-diagnosed-phall-100533028","NCT06220487","A Single-arm, Open-label Study of Olverembatinib, CD3\u002FCD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL","A Single-arm, Open-label Study of Olverembatinib, CD3\u002FCD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia","ABC","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Newly diagnosed adult B-precursor Ph+ ALL;\n3. Age greater or equal to 18 years;\n4. ECOG Performance Status 0-1;\n5. Ineligible for allo-HSCT.\n6. Renal and hepatic function as defined below:\n\n   AST (GOT), ALT (GPT), and AP \\\u003C2 x upper limit of normal (ULN). Creatinine clearance equal or greater than 50 mL\u002Fmin.\n7. Pancreatic function as defined below:\n\n   Serum amylase less or equal to 1.5 x ULN Serum lipase less or equal to1.5 x ULN\n8. Normal cardiac function;\n9. Negative HIV test, negative HBV DNA and HCV RNA;\n10. Negative pregnancy test in women of childbearing potential.\n\nExclusion Criteria:\n\nHistory of receiving systemic chemotherapy or CAR-T therapy for ALL.\n\nImpaired cardiac function, including any one of the following:\n\n.LVEF \\\u003C45% as determined by MUGA scan or echocardiogram. .Complete left bundle branch block. .Use of a cardiac pacemaker.\n\n* ST depression of \\>1mm in 2 or more leads and\u002For T wave inversions in 2 or more contiguous leads. .Congenital long QT syndrome. .History of or presence of significant ventricular or atrial arrhythmia. .Clinically significant resting bradycardia (\\\u003C50 beats per minute). .QTc \\>450 msec on screening ECG (using the QTcF formula). .Right bundle branch block plus left anterior hemiblock, bifascicular block. .Myocardial infarction within 3 months prior to starting olverembatinib . .Angina pectoris.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of olverembatinib or chidamide (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). .History of or current autoimmune disease. .History of or current relevant CNS pathology. .Presence of CNS leukemia. .History of or current autoimmune disease. .History of other malignancies. .Presence active infection.\n* Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.\n* Not eigiable for this study, decided by PI","18 Years",{"count":60,"type":20},67,[62],"PHASE2","ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3\u002FCD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3\u002FCD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for Ph+ ALL. Investigatorsaim to explore the efficacy and safety of ABC regimen. The primary endpoint is the complete molecular remission （CMR） at 3 months, secondary endpoints are overall survival (OS), event-free survival (EFS), adverse event (AE), IKZF1del, IKZF1plus, IKZF1lpus\u002FCD20 subgroup EFS\u002FOS.",[65,66,27,67,68],"Acute Lymphoblastic Leukemia","Philadelphia Chromosome","Adult ALL","IKZF1 Gene Mutation",[70,71,72,73,74,65,75],"Olverembatinib","CD3\u002FCD19 Bispecific T-cell Engager","Histone Deacetylase Inhibitor","Chidamide","Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia","Ph-positive","2024-01-21",{"date":78,"type":42},"2024-01-24",{"date":80,"type":20},"2024-02-01",{"date":82,"type":20},"2028-01-01",{"name":84,"class":48},"Nanfang Hospital, Southern Medical University",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100529586","treatment-protocol-for-newky-diagnosed-adult-ph-positive-all-100529586","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.",{"count":95,"type":20},150,"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.",[99,27,67],"Lymphoblastic Leukemia",[65,101,102],"Philadelphia (BCR::ABL1) positive","Adults","NOT_YET_RECRUITING","2023-12-15",{"date":106,"type":42},"2023-12-19",{"date":108,"type":20},"2023-12-25",{"date":110,"type":20},"2030-12-25",{"name":112,"class":48},"PETHEMA Foundation",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":85},"100510847","phase-2-a-study-of-olverembatinib-combined-with-blinatumomab-in-the-treatment-of-ph-all-100510847","NCT05931757","A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL","A Multicenter, Prospective Clinical Study of Olverembatinib Combined With Blinatumomab in the Treatment of Adult de Novo Philadelphia Chromosome Positive Acute Lymphoid Leukemia","Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older.\n2. Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy. Participants who only received preconditioning can be enrolled.\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.\n4. Organ function as indicated by the following laboratory indicators must be met:\n\n1\\) Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN; 2) Total bilirubin≤1.5×ULN; 3) Serum creatinine≤1.5×ULN or 24-hour calculated creatinine clearance≥50mL\u002Fmin when serum creatinine \\>1.5×ULN; 4) Amylase≤1.5×ULN, lipase≤1.5×ULN; 5) Cardiac ejection fraction (EF) \\> 50%, pulmonary artery systolic blood pressure ≤ 50mmHg; 6) QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females; 7) PT, APTT and INR≤1.5×ULN.\n\n5\\. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\n1. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCVpositive).\n2. Uncontrolled active infection.\n3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS.\n4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \\> 140mmHg and\u002For diastolic blood pressure \\> 90mmHg), or take medications that are known to cause QT interval prolongation. The patients with well controlled HBP can be considered to be included.\n5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \\>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension.\n6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL.\n7. Patients who have any other malignant tumors that require treatment.\n8. Patients who have a history of pancreatitis or a history of alcohol abuse.\n9. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol\u002FL).\n10. Patients who are pregnant, planning to become pregnant or breastfeeding.\n11. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug.\n12. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and\u002For fail to comply with all required study procedures.\n13. Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.","100 Years",{"count":122,"type":20},22,[62],"This is a multicenter, prospective, phase II study for adult de novo Philadelphia chromosome-positive acute lymphoid leukemia (Ph+ ALL) based on the combination of Olverembatinib and Blinatumomab. Olverembatinib will be taken 40mg qod from the time of diagnosis, and Blinatumomab will be given intravenously up to five cycles.",[27],"2023-07-01",{"date":128,"type":42},"2023-07-05",{"date":126,"type":20},{"date":131,"type":20},"2030-06-30",{"name":133,"class":48},"The First Affiliated Hospital of Soochow University"]