[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"philadelphia-positive-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:philadelphia-positive-acute-lymphoblastic-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,75],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637966","phase-1-a-study-of-lp-118-in-combination-with-ponatinib-dexamethasone-and-blinatumomab-for-adults-with-newly-diagnosed-bcrabl1-positive-acute-lymphoblastic-leukemia-all-100637966",false,"NCT07614022","A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)","A Phase I Study of the Bcl-2\u002FBcl-XL Inhibitor LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, Philadelphia-Chromosome\u002FBCR::ABL1-Positive Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an IRB-approved informed consent.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status (PS) ≤ 2.\n* Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome\u002FBCR::ABL1-positive ALL.\n* Creatinine clearance: ≥60 mL\u002Fmin, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.\n* Bilirubin ≤ 1.5 × upper limit of normal (ULN) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n* Aspartate aminotransferase (AST) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n* Alanine aminotransferase (ALT) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n* Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically infertile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).\n* ICBP must be willing to use two forms of contraception, one of which must be a barrier method and the other must be a highly effective contraceptive method from the time of informed consent until 6 months after study treatment discontinuation. Male participants with female partners of reproductive potential will need to agree to use contraception methods described above during study treatment and for at least 6 months after completion of all study treatment.\n* Male participants must agree to refrain from sperm donation during study treatment and for at least 6 months after completion of all study treatment.\n* Ability to ingest oral medications without a malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally, per the enrolling investigator.\n\nExclusion Criteria:\n\n* Any prior treatment for ALL except for a single dose of intrathecal (IT) chemotherapy, corticosteroids, hydroxyurea, a single dose of vincristine, cytarabine, leukapheresis, and\u002For a BCR::ABL1-targeted tyrosine kinase inhibitor. Permitted prior treatment is limited to a duration of no longer than 14 days. Permitted prior treatment must be stopped at least 24 hours prior to starting study therapy.\n* Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of all study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. Pregnant participants are excluded from this study because ponatinib, blinatumomab, and methotrexate have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ponatinib, blinatumomab, and methotrexate breastfeeding should be discontinued if the patient is treated with ponatinib, blinatumomab, and methotrexate.\n* Active second malignancy except for localized prostate cancer, basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the skin or cervix.\n* Unstable or severe uncontrolled medical condition in the opinion of the enrolling investigator (e.g., unstable cardiac function or unstable pulmonary condition; uncontrolled infection).\n* Participants with known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) are eligible if no evidence of active viral replication by blood testing (i.e. negative viral loads). HIV positive participants must be on active anti-retroviral therapy and willing to continue therapy during study treatment.\n* Uncontrolled cardiac disease as determined by the enrolling investigator.\n* Major surgery, as determined by the enrolling investigator, within 2 weeks before enrollment.","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer).",[26],"Philadelphia Positive Acute Lymphoblastic Leukemia",[28,29,30],"Leukemia","Philadelphia-Chromosome positive","cancer","NOT_YET_RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-05","ACTUAL",{"date":37,"type":20},"2026-10",{"date":39,"type":20},"2030-03",{"name":41,"class":42},"Wake Forest University Health Sciences","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100553064","efficacy-and-safety-of-tki-combined-with-chemotherapy-and-sequential-car-t-cells-in-nd-adult-patients-with-ph-all-100553064","NCT06481228","Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL","Efficacy and Safety of Molecular Targeted Therapy Combined With Chemotherapy and Sequential CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older\n2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and\u002For BCR-ABL positive and\u002F or FISH positive) acute lymphoblastic leukemia\n3. CD19 expression on blasts\n4. Expected survival time greater than 3 months\n5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%\n6. Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n1. Lymphoid blast crisis of chronic myelocytic leukemia (CML)\n2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and\u002For radiotherapy, except for appropriate pre-treatment)\n3. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)\n4. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n5. Known HIV seropositivity\n6. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis\n7. Uncontrolled hypertriglyceridemia (triglycerides \\>450 mg\u002FdL)\n8. Another malignancy diagnosed and treated within 5 years prior to diagnosis or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised should not be excluded\n9. Female patients who are pregnant or breast feeding\n10. Clinical manifestations of active CNS or extramedullary involvement with ALL\n11. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \\>7.5%. Patients with preexisting, well-controlled diabetes are not excluded\n12. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment\n13. Other conditions assessed by the investigators to be inappropriate for this study",{"count":52,"type":20},82,[54],"NA","In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed\u002Frefractory (R\u002FR）B-ALL. The available data suggest that the advancement of immunotherapy from R\u002FR field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.",[26,57],"Acute Lymphoblastic Leukemia, Adult",[59,60,61,62,63],"Ph-Positive Acute Lymphoblastic Leukemia","CAR-T cell","Venetoclax","olverembatinib","Newly Diagnosed","RECRUITING","2026-02-26",{"date":67,"type":35},"2026-03-02",{"date":69,"type":35},"2024-06-04",{"date":71,"type":20},"2028-06-01",{"name":73,"class":42},"Institute of Hematology & Blood Diseases Hospital, China",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100382468","phase-1-study-of-hqp1351-in-subjects-with-refractory-cml-and-ph-all-100382468","NCT04260022","Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL","A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)","Inclusion Criteria:\n\n* For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation\n* For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care\n* For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, number of pretreated TKIs is not restricted.\n\n  1. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:\n\n     1. Three months after the initiation of therapy: non-complete hematologic response (CHR) and\u002For Ph+ \\>95%\n     2. Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>35%\n     3. Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>0%\n     4. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n  2. The definition of resistance to second-line TKI treatment\n\n     a) For CML CP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: No CHR or Ph+ \\>95% or new mutations\n\n     ii.) Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>65% and\u002For new mutations\n\n     iii.) Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>35% and\u002For new mutations\n\n     iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n\n     b) For CML AP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR)\n\n     ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks\n\n     iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n\n     c) For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows:\n\n     i) One month after the initiation of therapy: failure to achieve a MaHR\n\n     ii) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week\n\n     iii) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n  3. Intolerance to TKIs is defined as:\n\n     1. Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n     2. Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n* Patients providing written informed consent before initiation of any study-related activities\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Minimum life expectancy of 3 months or more\n* Patients with adequate organ function as defined below:\n\n  1. Creatinine \\\u003C 2 × upper limit of normal (ULN); or, creatinine \\> 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (Cockcroft-Gault)\n  2. Serum albumin ≥ 3.0 g\u002FdL\n  3. Total bilirubin \\\u003C 1.5 × ULN\n  4. Aspartate aminotransferase (AST \\[Serum glutamic oxaloacetic transaminase (SGOT)\\]) and alanine aminotransferase (ALT \\[serum glutamate-pyruvate transaminase (SGPT)\\]) \\\u003C 3 × ULN for institution (\\\u003C5×ULN if liver involvement with leukemia)\n  5. Serum amylase and lipase ≤ 1.5 × ULN\n  6. Prothrombin time (PT) ≤ 1.5 × ULN\n* Heart function: Left ventricular ejection fraction (LVEF) \\> 50%\n* Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms\n* For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study\n* Ability to comply with study procedures, in the Investigator's opinion\n\nExclusion Criteria:\n\n* Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments\n* Received other therapies as follows:\n\n  1. For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351\n  2. For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351\n  3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351\n  4. Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351\n  5. Patients who had been treated with HQP1351\n  6. Patients requiring immunosuppressive therapy other than short time of steroid\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n* Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \\>140\u002F90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP can be considered to be included. (\"well controlled HBP\" is defined as: HBP can be ≤ 140\u002F90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.\n* Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  1. Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months\n  2. Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months\n  3. Any history of peripheral vascular infarction, including visceral infarction within 6 months\n  4. Congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment\n  5. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia\n  6. Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.\n  7. Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.\n* Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression in recent 6 months prior to informed consent date\n* CML CP patients with CCyR\n* Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL\n* Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment\n* Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)\n* Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.\n* Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV antibody must have an undetectable HCV viral load.\n* Patients with COVID-19 who now present with positive swab\n* Patients who have poorly controlled diabetes, defined as HbA1C values of \\> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.\n* Known allergy to any components in the study drug\n* Pregnant or lactating\n* Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug",{"count":83,"type":20},242,[23],"A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.",[87,88,89,26,90],"Leukemia, Myeloid, Chronic","Myeloid Leukemia","Chronic Myeloid Leukemia","B Cell Precursor Type Acute Leukemia",[92,93,94,95,96],"T315I mutation","Chronic Phase","Accelerated Phase","Blast Phase","Lymphoid blast phase","2025-11-04",{"date":99,"type":35},"2025-11-05",{"date":101,"type":35},"2020-01-09",{"date":103,"type":20},"2030-03-31",{"name":105,"class":106},"Ascentage Pharma Group Inc.","INDUSTRY",9]