[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-acute-myeloid-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,67,95,119,144],{"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},"100571003","phase-1-evaluate-the-safety-tolerability-pharmacokinetic-profile-efficacy-of-bl-m11d1-100571003",false,"NCT06714591","Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1","A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-M11D1 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia.","Inclusion Criteria:\n\n1. Signed the informed consent\n2. Age ≥18 years\n3. Has a life expectancy of ≥3 months\n4. Relapsed and\u002For refractory CD33-positive AML as determined by local pathology review that has failed initial standard of care therapy. Diagnosis of primary AML or AML secondary to myelodysplastic syndromes. Relapsed or refractory status. CD33-positive as confirmed by local flow cytometry or cytology\n5. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2\n6. Toxicity of previous anticancer therapy has returned to Grade ≤1 as defined by NCI CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n7. Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN b. Renal function: Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration \\[CKD-Epi\\], or Modification of Diet in Renal Disease Study \\[MDRD\\] equations)\n8. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months after the last dose of study treatment. An additional contraceptive method, such as a barrier method (eg, condom), is recommended\n9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating\n\nExclusion Criteria:\n\n1. Subjects with acute promyelocytic leukemia (APL) or chronic myelogenous leukemia in blast crisis (CML)\n2. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy within 2 weeks) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration, or palliative radiotherapy within 2 weeks prior to the first administration\n3. Subjects with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable cardiac arrhythmias or angina pectoris within 6 months before screening\n4. Subjects with prolonged QT interval (QTcF \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block or a history of additional risk factors for Torsades de Pointes (TdP; eg, heart failure as defined in Exclusion Criterion 3, chronic or recurrent hypokalemia that requires medical intervention, congenital long QT syndrome, family history of long QT syndrome) or any current concomitant medication known to prolong the QT\u002FQTc interval or cause TdP\n5. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)\n6. Subjects with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with as disease-free interval of at least 1 year\n7. Subjects with poorly controlled hypertension or uncontrolled hypertension by two or more antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n8. Subjects with active acute or chronic graft vs. host disease (aGVHD or cGVHD) should be excluded from this study. Subjects with GVHD who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone should also be excluded from the study; however, treatment with low-dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted\n9. Subjects currently receiving immunosuppressive therapy should be excluded from this study.\n10. Clinical evidence of disseminated intravascular coagulation (DIC). Smoldering low grade DIC is allowed after discussion with the sponsor\n11. Subjects with stroke or transient ischemic attack (TIA) within 6 months before screening\n12. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before screening except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before screening\n13. Subjects with active central nervous system (CNS) AML will be excluded. A lumbar puncture does not need to be performed unless there is clinical suspicion of CNS involvement per investigator judgment. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS AML is allowed with the approval of the sponsor\n14. Subjects with pre-existing ≥Grade 2 peripheral neuropathy\n15. Subjects with advanced\u002F clinically significant lung diseases, such as poorly controlled COPD and asthma, restrictive lung disease, pulmonary hypertension etc.\n16. Subjects who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n17. Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M11D1\n18. Subjects with known human immunodeficiency virus infection (HIV Ab positive) Subjects are allowed to participate if all of the following criteria are met: (1) Undetectable HIV RNA and CD4 count ≥350 cells\u002FμL at screening, (2) No AIDS defining opportunistic infection within 12 months prior to screening, (3) On stable antiretroviral therapy (ART) for at least 4 weeks prior to screening with projected continuation of ART as clinically indicated while on the study\n19. Subjects with active Hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with chronic inactive HBV infection are eligible if they meet all of the following criteria:\n\n    1. Have a HBV DNA viral load ≤ 500 IU\u002FmL\n    2. Have normal AST and ALT, OR if liver involvement is present, has AST and ALT \\\u003C3 × ULN which are not attributed to HBV infection\n    3. on antiviral treatment, as clinically indicated\n20. Subjects with active Hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA\n21. Subjects with active or latent tuberculosis\n22. Subjects with active and uncontrolled infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n23. Received an investigational drug within 2 weeks prior to first dose of study treatment.\n24. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n25. Prior treatment with a topoisomerase inhibitor-based antibody-drug conjugate (ADC.)\n26. Previous history of significant gastrointestinal conditions, including Grade 3 or higher diarrhea, colitis, gastrointestinal bleeding and history of major gastrointestinal surgeries\n\n28\\. Progressed on more than 2 different lines of systemic cytotoxic therapies; patients with 3 prior lines of systemic cytotoxic therapy or with prior allogeneic stem cell transplant may be enrolled upon consultation and approval from the sponsor","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed\u002Frefractory acute myeloid leukemia.",[26],"Relapsed\u002FRefractory Acute Myeloid Leukemia","RECRUITING","2026-06-24",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":31},"2024-12-19",{"date":35,"type":20},"2027-03-30",{"name":37,"class":38},"SystImmune Inc.","INDUSTRY",18,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100636977","salvage-haploidentical-hsct-with-dli-and-targeted-therapy-for-rr-aml-100636977","NCT07572695","Salvage Haploidentical HSCT With DLI and Targeted Therapy for R\u002FR AML","Salvage Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation Combined With Post-transplant Relapse Prevention Strategies for Relapsed\u002FRefractory Acute Myeloid Leukemia (AML): A Prospective Observational Study","Inclusion Criteria:\n\n* Signed and dated informed consent Willing and able to comply with all study procedures and follow-up Adults aged 18 to 65 years Diagnosis of acute myeloid leukemia (AML) Active disease before transplantation, defined as bone marrow blasts \\>5% or presence of extramedullary disease HCT-CI (Hematopoietic Cell Transplantation-Comorbidity Index) score ≤5\n\nExclusion Criteria:\n\n* Bone marrow blasts ≤5% without extramedullary disease before transplantation Age \\\u003C18 years or \\>65 years HCT-CI score \\>5 Patients with other diagnoses besides AML","65 Years",{"count":49,"type":20},40,"24 Months","OBSERVATIONAL","This is a prospective, single-center, observational study to evaluate the efficacy and safety of salvage haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) combined with post-transplant relapse prevention strategies in patients with relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML).\n\nEligible patients are adults aged 18-65 years with active AML (bone marrow blasts \\>5% or extramedullary disease) and HCT-CI score ≤5. All patients will receive a uniform conditioning regimen consisting of fludarabine, busulfan, and MECCNU, with addition of targeted agents (such as sorafenib, midostaurin, or venetoclax) according to mutation status. Graft-versus-host disease (GVHD) prophylaxis includes reduced-dose ATG (6 mg\u002Fkg), FK506, MMF, and basiliximab. Post-transplant maintenance with targeted therapy or azacitidine and prophylactic donor lymphocyte infusion (DLI) will be administered to reduce relapse risk.\n\nThe primary endpoints are cumulative incidence of relapse (CIR), overall survival (OS), and progression-free survival (PFS). Secondary endpoints include incidence of acute and chronic GVHD, CMV\u002FEBV reactivation, non-relapse mortality (NRM), and GVHD-free, relapse-free survival. Patients will be followed for 24 months after transplantation. This study aims to explore an optimized transplant strategy to improve long-term survival in this high-risk population.",[54,26,55],"Acute Myeloid Leukemia","AML, Relapsed\u002FRefractory","NOT_YET_RECRUITING","2026-05-03",{"date":59,"type":31},"2026-05-07",{"date":61,"type":20},"2026-04-30",{"date":63,"type":20},"2028-12",{"name":65,"class":66},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100569638","phase-1-cd70-car-nk-cell-therapy-for-t-cell-lymphoma-and-acute-myeloid-leukemia-100569638","NCT06696846","CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia","Cord Blood-derived CD70-targeting CAR-NK Cell Therapy for Refractory\u002FRelapsed T Cell Lymphoma and Acute Myeloid Leukemia","Inclusion Criteria:\n\nAccording to the WHO disease classification, patients with relapsed\u002Frefractory T - lymphoma and acute myeloid leukemia:\n\n1. Voluntarily participate in this study and sign the informed consent form;\n2. Aged between 18-75 years old, both male and female are eligible;\n3. Relapsed\u002Frefractory T cell lymphoma is defined as: relapsed\u002Frefractory after having received at least two or more lines of previous treatment (patients with anaplastic large -cell lymphoma must have been exposed and resistant to Brentuximab vedotin). The celluar subtypes of T-cell lymphoma include: angioimmunoblastic T-cell lymphoma; peripheral T - cell lymphoma not otherwise specified; ALK-negative anaplastic large - cell lymphoma; Relapsed\u002Frefractory AML is defined as: leukemia cells reappear in the peripheral blood after complete remission or the blasts in the bone marrow ≥ 5% or the extramedullary leukemia infiltration outside. Or newly diagnosed cases did not achieve a CR after two courses of standard regimens; those who relapse within 12 months after CR after consolidation and intensification treatment; those who relapse after 12 months and have not responded to conventional chemotherapy; those who relapse two or more times; those with persistent extramedullary leukemia;\n4. The expected survival period ≥ 12 weeks;\n5. CD70 expression is positive in tumor tissue puncture sections\u002Ftumor cells detected by flow cytometry, and the number of CD70 - positive cells detected by immunohistochemistry ≥ 20% (++ or more);\n6. ECOG score is 0 - 2;\n7. Adequate organ function reserve:\n\n   * Alanine aminotransferase and aspartate aminotransferase ≤ 2.5× UNL;\n   * Creatinine clearance rate (Cockcroft - Gault method) ≥ 60 mL\u002Fmin;\n   * Serum total bilirubin and alkaline phosphatase ≤ 1.5× UNL;\n   * Glomerular filtration rate \\> 50 ml\u002Fmin;\n   * Cardiac ejection fraction ≥ 45%;\n   * Under indoor natural air environment, the basic oxygen saturation \\> 92%;\n   * Routine blood test: absolute neutrophil count \\> 1000\u002Fmm3, platelet count ≥ 45×109, hemoglobin ≥ 8.0g\u002Fdl (the standard for AML patients is ≥ 7.0g\u002Fdl; blood transfusion is allowed);\n8. Previous autologous hematopoietic stem cell transplantation is allowed once;\n9. Patients who have previously received CAR - T cell therapy and were evaluated as ineffective after 3 months or relapsed after CR are allowed;\n10. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial period;\n11. No active lung infection, and indoor air blood oxygen saturation ≥ 92%;\n12. Before the study drug is used, approved anti - tumor treatment methods, such as systemic chemotherapy, whole - body radiotherapy, and immunotherapy, have been completed for at least 3 weeks; the wash - out period for targeted drug regimens without chemotherapy is 2 weeks;\n13. Two negative tests for COVID - 19 or influenza A.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be eligible for this study:\n\n1. Those with a history of allergy to any component in the cellular product;\n2. Those with a history of other tumors;\n3. Those who had grade II - IV (Glucksberg criteria) acute GvHD or extensive chronic GvHD after previous allogeneic hematopoietic stem cell transplantation; or those who are currently receiving anti - GvHD treatment;\n4. Those who have received gene therapy within the past 3 months;\n5. Those with active infections requiring treatment (except for simple urinary tract infections and bacterial pharyngitis). However, prophylactic antibiotic, antiviral, and antifungal treatments are permitted;\n6. Subjects with hepatitis B (HBsAg - positive, but HBV - DNA \\\u003C 103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis, and other acquired or congenital immunodeficiency diseases, including but not limited to those infected with the AIDS virus;\n7. Subjects with grade III or IV cardiac insufficiency according to the New York Heart Association cardiac function classification standard of the United States;\n8. Those whose toxic reactions from previous anti - tumor treatment have not recovered (CTCAE 5.0 toxic reactions have not recovered to ≤ grade 1, except for fatigue, anorexia, and alopecia);\n9. Subjects with a history of epilepsy or other central nervous system diseases;\n10. Lactating women who are unwilling to stop breastfeeding;\n11. Any other circumstances that, in the opinion of the investigator, may increase the risk to the subject or interfere with the test results;\n12. Those with positive nucleic acid tests for COVID - 19 or influenza A.","75 Years",{"count":76,"type":20},25,[23],"CD70 is a promising target for immunotherapy because it is overexpressed in T-cell lymphoma (TCL) and acute myeloid leukemia (AML) tumor cells but is found in deficient levels in normal tissues and hematopoietic stem cells. This study aims to evaluate the safety and efficacy of CD70-targeted CAR-NK (CD70-CAR-NK) cells in patients with relapsed and refractory TCL and AML.",[80,26],"Relapsed\u002FRefractory T-cell Lymphoma",[82,83,84,85],"CD70","CAR-NK","T cell lymphoma","acute myeloid leukemia","2026-04-26",{"date":61,"type":31},{"date":89,"type":31},"2024-12-01",{"date":91,"type":20},"2028-11-30",{"name":93,"class":66},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":74,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":94},"100522607","phase-2-clinical-study-of-venetoclax-combined-with-cacag-regimen-in-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100522607","NCT06084819","Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patients who are able to understand and willing to sign the informed consent form (ICF).\n* All patients should aged 14 to 75 years,no gender limitation.\n* Patients with R\u002FR AML, diagnosed in accordance with the 2021 edition of the CMA criteria\n* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;\n* Renal function: creatinine ≤the upper limit of normal;\n* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;\n* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.\n* Patients without severe allergic constitution.\n\nExclusion Criteria:\n\n* Patients with allergy or contraindication to the study drug;\n* Female patients who are pregnant or breast-feeding.\n* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;\n* Patients with mental illness or other states unable to comply with the protocol;\n* Less than 6 weeks after surgical operation of important organs.\n* Liver function: ALT and AST\\>2.5 times the upper limit of normal ,bilirubin\\>2 times the upper limit of normal;Renal function: creatinine \\>the upper limit of normal;\n* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)","14 Years",{"count":104,"type":20},200,[106],"PHASE2","The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed\u002Frefractory acute myeloid leukemia.",[26],[26],"2026-03-29",{"date":112,"type":31},"2026-04-02",{"date":114,"type":31},"2023-08-01",{"date":116,"type":20},"2030-01-31",{"name":118,"class":66},"Chinese PLA General Hospital",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100558336","phase-1-study-of-nms-03597812-in-adult-patients-with-relapsedrefractory-acute-myeloid-leukemia-100558336","NCT06549790","Study of NMS-03597812 in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase Ia\u002FIb Study of NMS-03597812 in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia Including Patients With TP53 Mutations","Inclusion Criteria:\n\n* Confirmed diagnosis of refractory\u002Frelapsed (R\u002FR) AML according to 2022 ELN recommendation:\n\nPhase Ia\n\n* single agent dose escalation of NMS-03597812: R\u002FR AML patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of hypomethylating agents (HMA)\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n\nPhase Ib\n\n* Cohort A: single agent in R\u002FR AML TP53mt patients who have exhausted standard therapy: a) prior unfit to intensive chemotherapy (IC): failed at least 2 cycles of HMA\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; b) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n* Cohort B: single agent in R\u002FR AML TP53wt patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of HMA\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n* Adult (age ≥ 18 years) patients\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Unless agreed with sponsor, the interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever is longer, other than hydroxyurea\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade≤ 1\n* Adequate organ function\n* Must use highly effective contraception or true abstinence. Female patients must be surgically sterile or, if patient is of childbearing potential, must agree to use effective contraception of therapy and in the following 210 days after discontinuation of study treatment. Since NMS-03597812 has potential induction of CYP3A4, women of childbearing potential must be advised that hormonal contraceptives might lose efficacy and must use alternate form of highly effective contraception. Male patients must be surgically sterile or must agree to use highly effective contraception or true abstinence during the period of therapy and in the following 120 days for male patients who must refrain from donating sperm during this period after discontinuation of study treatment.\n* Capability to swallow capsules intact (without chewing, crushing, or opening)\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures\n* Signed and dated Independent Ethics Committee (IEC) or Institutional Review Board (IRB)-approved informed consent form indicating that the patient is aware of the neoplastic nature of his\u002Fher disease and has been informed of the procedures to be followed, the investigational nature of the therapy, potential benefits, side effects, discomforts, risks, and alternative treatments.\n\nExclusion Criteria:\n\n* Current enrollment in another interventional clinical study unless only participating in survival follow up\n* White blood cells (WBC) count \\>20×10\\^3\u002Fmicroliter (μL). However, patients can be treated with hydroxyurea and\u002For leukapheresis prior to study treatment start to reduce the WBC to ≤ 20×10\\^3\u002FμL to enable eligibility for study drug dosing.\n* Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia\n* Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and\u002For cone biopsied in situ carcinoma of the cervix uteri and\u002For superficial bladder cancer.\n* Patients with known leukemia involvement of central nervous system (CNS).\n* Hematopoietic stem cell transplantation (HSCT) within 3 months of treatment start and\u002For persistent non- hematologic toxicities of Grade ≥2 related to the transplant\n* Active acute or chronic graft versus host disease (GVHD) requiring immunosuppressive treatment\n* Patients with QTcF interval ≥ 470 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment needs to be considered. If replacement or discontinuation is not clinically feasible, a careful risk\u002Fbenefit evaluation should be performed prior to enrollment.\n* Pregnancy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of study drug.\n* Breast-feeding or planning to breast feed during the study or within 90 days after study treatment.\n* Known active gastrointestinal disease (eg, gastro-duodenal ulcer, gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* Patient who are receiving concomitant medications with antacids (proton pump inhibitors are strictly prohibited; calcium carbonate antacids are only allowed 6 hours prior to a dose or 1 hour after). Note: exclusion criterion not applicable to optional backfill cohort for investigation of drug-drug interaction with antiacids.\n* Patient who are receiving concomitant medications that are strong inducers or inhibitors of CYP3A4 (with the exception of azole antifungals) and CYP2C9 that cannot be replaced with alternative therapy.\n* Patients who are receiving concomitant medications that are sensitive substrates of CYP3A4,CYP2D6, CYP1A2 and CYP2B6 with narrow therapeutic window that cannot be replaced with alternative therapy. Drugs with broad therapeutic indices may still be acceptable.\n* Patients who are receiving concomitant medications that are strong or moderate P-gp inhibitors that cannot be replaced with alternative therapy.\n* Major surgery within 4 weeks before study treatment start.\n* Radiotherapy within 4 weeks before study treatment start. However, if the radiation portal covered ≤5 % of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.\n* History of necrotic pancreatitis or acute severe pancreatitis, requiring medical intervention and\u002For hospitalization, in the previous 6 months before study treatment start.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":127,"type":20},124,[23],"The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed\u002FRefractory Acute Myeloid Leukemia (R\u002FR AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.",[26],[132,26,133],"Leukemia","TP53 mutations","2025-10-30",{"date":136,"type":31},"2025-10-31",{"date":138,"type":31},"2024-10-16",{"date":140,"type":20},"2030-05-15",{"name":142,"class":38},"Nerviano Medical Sciences",7,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":94},"100557694","early-phase-1-safety-and-efficacy-of-nk520-to-treat-relapsedrefractory-acute-myeloid-leukemia-100557694","NCT06541444","Safety and Efficacy of NK520 to Treat Relapsed\u002FRefractory Acute Myeloid Leukemia","An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK520 for Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Participants must be between 18 and 75 years;\n2. Diagnostic Criteria:\n\n   Meet the 2016 World Health Organization (WHO) diagnostic criteria for AML, unsuitable for current treatments or patients with relapsed\u002Frefractory AML after ≥2 lines of therapy. The definition of relapsed\u002Frefractory acute myeloid leukemia is based on the 2017 Chinese Guidelines for Diagnosis and Treatment:\n   1. Relapsed AML: Diagnosis is confirmed when leukemia cells reappear in the peripheral blood or bone marrow blast cells exceed 5% after complete remission (CR) (excluding reasons such as bone marrow regeneration post-consolidation chemotherapy) or there is extramedullary infiltration by leukemia cells;\n   2. Refractory AML: Initial cases unresponsive after two cycles of standard regimen treatment; recurrence within 12 months after CR and consolidation therapy; recurrence beyond 12 months with ineffectiveness of conventional chemotherapy; those who have relapsed twice or more; or persistent extramedullary leukemia;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n4. Expected survival of at least 12 weeks;\n5. Normal Organ Function.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia;\n2. Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;\n3. Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;\n4. HIV-infected individuals, or known active syphilis infection;\n5. Use of immunosuppressive drugs within 1 week before the first dose, excluding topical, inhaled, or other locally administered glucocorticoids, or physiologic doses of systemic glucocorticoids (not exceeding 10 mg\u002Fday prednisone equivalent) for allergic reactions or for managing respiratory distress from asthma, COPD, etc;\n6. Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;\n7. Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;\n8. Receipt of immune-modulating drugs (including thymosin, interferons, except for local use to control pleural or ascitic fluid) within 2 weeks prior to the first dose;\n9. At screening, hepatitis B or C viral tests positive according to either:\n\n   * HBsAg positive with serum HBV-DNA titer ≥1×10\\^3 copies\u002FmL or above normal limits;\n   * HCV antibody positive;\n10. Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.",{"count":152,"type":20},9,[154],"EARLY_PHASE1","This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed\u002Frefractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.",[26],"2024-08-05",{"date":159,"type":31},"2024-08-07",{"date":161,"type":31},"2024-07-01",{"date":163,"type":20},"2026-06-01",{"name":165,"class":38},"Base Therapeutics (Shanghai) Co., Ltd."]