[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"philadelphia-chromosome-positive-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:philadelphia-chromosome-positive-acute-lymphoblastic-leukemia":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,80,102,130],{"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},"100598669","early-phase-1-efficacy-safety-and-pharmacokinetics-of-thiscart19a-combined-with-olverembatinib-in-patients-with-newly-diagnosed-philadelphia-chromosome-positive-acute-lymphoblastic-leukemia-100598669",false,"NCT07074496","Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.","An Open, Prospective, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Combined With a Novel Third-generation TKI Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic 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.\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) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin\\\u003C2×ULN; 3. 24-hour calculated creatinine clearance\\>30 mL\u002Fmin; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;\n\nExclusion Criteria:\n\n1. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU\u002FmL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA \\\u003C 2000 IU\u002FmL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;\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);\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 severe hypertriglyceridemia (triglyceride ≥ 5.6mmol\u002FL);\n9. Patients who are pregnant, planning to become pregnant or breastfeeding;\n10. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;\n11. 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;\n12. 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.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.",[26],"Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","RECRUITING","2026-06-15",{"date":30,"type":31},"2026-06-17","ACTUAL",{"date":33,"type":31},"2024-01-01",{"date":35,"type":20},"2028-07-01",{"name":37,"class":38},"The First Affiliated Hospital of Soochow University","OTHER",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100622769","phase-1-safety-and-efficacy-of-asciminib-in-pediatrics-and-young-adults-with-relapserefractory-rr-philadelphia-positive-ph-or-abl-class-ph-like-acute-lymphoblastic-leukemia-all-100622769","NCT07387926","Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse\u002FRefractory (r\u002Fr) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)","Open-label, Phase I\u002FII Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL","Inclusion Criteria:\n\n* Evidence of Ph+ ALL or ABL1 or ABL2 fusion Ph-like ALL, inclusive of participants with ABL1 T315I mutation\n* Participants with CNS1, CNS2, CNS3a, or CNS3b at screening\n* Active B-Cell ALL at screening defined by MFC or IG\u002FTCR PCR of ALL blasts \\>0.01% in participants with either:\n\n  1. Primary refractory disease (\\>0.01% ALL blasts present at the end of consolidation) OR\n  2. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG\u002FTCR PCR \\>0.01%) after at least one line of therapy\n* Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry).\n\n  a) For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1\n* Adequate hepatic and renal function (local laboratory analysis) as defined:\n\n  1. ALT ≤ 5x upper limit of normal (ULN) for age\n  2. Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN) for age, except for participants with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n  3. Estimated glomerular filtration rate (eGFR) using the Cockcroft-Gault formula in participants ≥ 18 years, OR radioisotope GFR ≥50 mL\u002Fmin\u002F1.73 m\\^2, OR creatinine based on age and sex for participants \\\u003C 18 years old\n* Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by ECHO\n\nExclusion Criteria:\n\n* Participants with \\>3 relapses of ALL\n* Extramedullary disease (non-CNS and\u002For isolated CNS disease)\n* Participants with CNS3c (Clinical signs of CNS leukemia (such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome))\n* Cardiac or cardiac repolarization abnormality, including but not limited to clinically significant cardiac arrhythmias, long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or other clinically significant heart disease (e.g., congestive heart failure, etc.)\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.","1 Year","30 Years",{"count":50,"type":20},50,[52,53],"PHASE1","PHASE2","Multi-center, open-label, single arm study of asciminib in participants aged ≥1 year to ≤30 years old with r\u002Fr Ph+ or ABL-class Ph-like ALL. This study will have 2 parts: Part 1 dose escalation and Part 2 dose expansion. Part 1 dose escalation will enroll participants aged ≥1 year to ≤30 years to determine the recommended phase 2 dose (RP2D) of asciminib when administered with low intensity chemotherapy. Part 2 dose expansion will enroll participants aged ≥1 year to ≤30 years to evaluate safety, tolerability, and efficacy of asciminib at the RP2D with the treatment regimen.",[56,57,58],"Acute Lymphoblastic Leukemia","Leukemia, Lymphoblastic, Acute, Philadelphia-Positive","Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[60,61,62,63,64,65,66,67,68],"Asciminib","ABL001","Ph+ chromosome acute lymphoblastic leukemia","ABL1\u002FABL2 fusion Ph-like ALL","BCR::ABL1","blinatumomab","dexamethasone","vincristine","chemotherapy","NOT_YET_RECRUITING","2026-05-15",{"date":72,"type":31},"2026-05-19",{"date":74,"type":20},"2026-07-30",{"date":76,"type":20},"2036-06-18",{"name":78,"class":79},"Novartis Pharmaceuticals","INDUSTRY",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100612169","phase-1-asciminib-maintenance-therapy-following-allohct-or-car-t-to-prevent-relapse-in-adults-with-phall-100612169","NCT07250087","Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL","Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities\n* Morphologic remission (\\\u003C5% marrow blasts)\n* ECOG performance status 0-2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Active relapsed disease (\\>5% blasts)\n* Grade II-IV acute GVHD requiring systemic steroids\n* Significant organ dysfunction or uncontrolled infection\n* Pregnancy or breastfeeding\n* Prior investigational CAR T product",{"count":88,"type":20},36,[52],"The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome\n\nPositive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults:\n\none group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.",[58],"2026-03-26",{"date":94,"type":31},"2026-03-27",{"date":96,"type":31},"2026-01-21",{"date":98,"type":20},"2029-11",{"name":100,"class":38},"H. Lee Moffitt Cancer Center and Research Institute",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100620387","evaluation-of-the-efficacy-of-ponatinib-in-ph-all-in-the-real-world-100620387","NCT07356960","Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world","Retrospective, Observational, Study on the Evaluation of the Real-world Outcome of Philadelphia-positive Acute Lymphoblastic Leukaemia Patients Treated With Ponatinib as First-line Treatment Under the Italian Law 648\u002F96 (PONA4ALL Ph+)","PONA4ALL Ph+","Inclusion Criteria:\n\n1. Patient is \\> 18 years old;\n2. Patient was treated in first-line with ponatinib monotherapy or in association with chemotherapy or immunotherapy;\n3. Patient received ponatinib under the regulations of Law 648\u002F96;\n4. \\- Patient is alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR\n\n   \\- has died\u002Flost to follow-up at any time after treatment initiation, regardless of the length of available follow-up;\n5. Signed informed consent, if applicable.\n\nExclusion Criteria:\n\n* None",{"count":111,"type":20},103,"OBSERVATIONAL","The goal of this retrospective observational study is to learn about the efficacy of ponatinib in Philadelphia-positive ALL (Ph+ ALL) patients in a real-world setting. The main goal of the study is to assess the rate of complete molecular response (CMR) induced by ponatinib in patients treated under the regulations of Law 648\u002F96, outside clinical trials.\n\nPatients who were treated with ponatinib as part of their regular medical care and completed the follow-up period will be included in the study.",[115,58],"Acute Lymphobkastic Leukemia",[117,118,119,120,121],"ponatinib","real-world","philadelphia-positive acute lymphoblastic leukemia","Ph+ ALL","adult","2026-01-12",{"date":96,"type":31},{"date":125,"type":20},"2026-04-02",{"date":127,"type":20},"2029-06-30",{"name":129,"class":38},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100520786","phase-2-randomized-trial-in-adult-de-novo-ph-positive-all-with-chemotherapy-imatinib-or-ponatinib-blinatumomab-and-sct-100520786","NCT06061094","Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT","A Multicentre, Randomized Trial in Adults With de Novo Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia to Assess the Efficacy of Ponatinib Versus Imatinib in Combination With Low-intensity Chemotherapy, to Compare End of Therapy With Indication for SCT Versus TKI, Blinatumomab and Chemotherapy in Optimal Responders and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE)","GMALL-EVOLVE","Inclusion Criteria:\n\n* Male or female patients \\>= 18 years, \\\u003C=65 years\n* Philadelphia chromosome or BCR-ABL1 positive ALL\n* Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib)\n* ECOG performance status ≤2\n* Signed written inform consent\n* Molecular evaluation for BCR-ABL1 performed\n* Negative pregnancy test in women of childbearing potential\n* Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%).\n* Normal serum levels \\> LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication\n* Serum lipase ≤ 1.5 x ULN. For serum lipase \\> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis\n* Normal QTcF interval ≤450 ms for males and ≤470 ms for females\n* Signed and dated written informed consent is available\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions\n* Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab\n* Patient previously treated with tyrosine kinase inhibitors\n* Nursing women\n* Known impaired cardiac function, including any of the following: as detailed in protocol\n* Symptomatic peripheral vascular disease\n* Any history of ischemic stroke or transient ischemic attacks (TIAs)\n* Uncontrolled hypertriglyceridaemia\n* History or presence of clinically relevant CNS pathology as detailed in protocol\n* History or active relevant autoimmune disease\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C\n* History of pancreatitis within 6 months previous to start of treatment within the trial\n* Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study\n* Inadequate hepatic functions defined as ASAT or ALAT \\> 2,5 times the institutional upper limit of normal or \\> 5 times ULN if considered due to leukemia\n* Total bilirubin \\> 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert \u002F M. Meulengracht\n* Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections\n* Inability to understand and\u002For unwillingness to sign a written informed consent","65 Years",{"count":140,"type":20},220,[53],"The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation.\n\nThe EVOLVE trial aims to answer three questions challenging the current SoC:\n\nUse of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).\n\nIn MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II).\n\nIn MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).",[58],[58,145,146],"Tyrosinekinase Inhibitors","Blinatumomab","2025-04-25",{"date":149,"type":31},"2025-04-29",{"date":151,"type":31},"2023-07-14",{"date":153,"type":20},"2029-07-01",{"name":155,"class":38},"Goethe University",85]