[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lomond Therapeutics Holdings, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,77],{"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":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100570565","phase-1-a-study-of-lonitoclax-ze50-0134-in-relapsed-or-refractory-b-cell-malignancies-100570565",false,"NCT06708897","A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies","Phase 1 Study of Lonitoclax (ZE50-0134) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas","Inclusion Criteria:\n\n1. Men and women aged 18 years or older.\n2. Disease as defined below:\n\n   * Part 1: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; or progressive low-grade lymphoma, including marginal zone lymphoma or lymphoplasmacytic lymphoma (including Waldenstrom macroglobulinemia), after at least 1 prior therapy that included either a BTKi or CD20 antibody-based therapy.\n   * Part 2: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive.\n3. Disease requiring therapy in the investigator's opinion.\n4. Adequate bone marrow, liver, and renal function during screening:\n\n   * Absolute neutrophil count greater than 0.75 x 10\\^9\u002FL; for participants with documented bone marrow involvement, at least 0.5 x 10\\^9\u002FL.\n   * Platelet count greater than 50 x 10\\^9\u002FL; for participants with documented bone marrow involvement, at least 30 x 10\\^9\u002FL.\n   * AST and ALT no greater than 3.0 times the upper limit of normal.\n   * Total bilirubin no greater than 1.5 times the upper limit of normal. Participants with suspected or known Gilbert disease may have total bilirubin up to 3 times the upper limit of normal if predominantly unconjugated.\n   * Creatinine- or cystatin C-based glomerular filtration rate at least 60 mL\u002Fmin, or at least 40 mL\u002Fmin with a normal urine neutrophil gelatinase-associated lipocalin level. Estimated GFR is calculated using the Modification of Diet in Renal Disease formula.\n5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2.\n6. For women of childbearing potential, a negative serum or urine pregnancy test within 7 days before the first dose and a negative result before each treatment cycle. Pregnancy testing is not required for women older than 50 years with at least 12 months of amenorrhea; women aged 50 years or younger with at least 6 months of spontaneous amenorrhea and follicle-stimulating hormone greater than 40 mIU\u002FmL; or permanently sterilized women, including hysterectomy, bilateral salpingectomy, or uterine ablation.\n7. Women and men of reproductive potential must agree to use highly effective contraception from signing informed consent until 90 days after the last dose of study drug.\n8. Ability to understand and willingness to sign written informed consent, including consent for genetic biomarker analyses from tissue and plasma, before study-specific procedures.\n\nExclusion Criteria:\n\n1. Part 2 only: Prior venetoclax treatment.\n2. Known active Richter transformation. Participants previously treated for Richter transformation may be eligible if they have been in remission for more than 2 years, have no evidence of Richter transformation, and have CLL only.\n3. Known hypersensitivity to lonitoclax, its excipients, or an agent administered in association with the study.\n4. Clinically significant cardiac disease, including congestive heart failure greater than New York Heart Association Class II; uncontrolled coronary artery disease; unstable angina; new-onset angina or myocardial infarction within 6 months before first dose; major regional wall-motion abnormalities on baseline echocardiography; or cardiac arrhythmias requiring antiarrhythmic treatment other than beta-blockers or digoxin.\n5. Known active cytomegalovirus, hepatitis B virus, or hepatitis C virus infection.\n6. HIV-positive disease that is not adequately controlled by antiviral therapy. Participants with adequately controlled HIV may enroll.\n7. Known active SARS-CoV-2 infection. Prior infection is allowed if the participant completely recovered more than 14 days previously.\n8. Active clinically serious infection of Grade greater than 2 requiring parenteral therapy. Participants may be eligible after the infection resolves.\n9. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days before enrollment.\n10. Allogeneic bone marrow transplant within 4 months before first dose. Immunosuppressive therapy related to the transplant must be completed before enrollment.\n11. Active cancer that limits expected survival to less than 2 years or requires anticancer therapy concomitantly with study treatment. Exceptions may include resected localized skin, breast, or prostate cancer and malignancies treated with hormonal or immune therapies alone; secondary cancers should be discussed with the Medical Monitor.\n12. Physical examination or laboratory finding that contraindicates investigational therapy or otherwise places the participant at excessively high treatment risk in the investigator's opinion.\n13. Requirement for ongoing immunosuppressive therapy, including systemic corticosteroids, for cancer or another condition. Topical or inhaled corticosteroids and low-dose systemic steroids of no more than 20 mg prednisone equivalent per day are permitted for comorbid conditions. Short courses above this dose before first dose and during Week 1 may be used for tumor flare.\n14. Major surgery or significant trauma within 4 weeks before first dose.\n15. Breastfeeding. Breastfeeding must be discontinued before and during treatment and for at least 3 months after treatment ends.\n16. QT interval corrected using Fridericia's formula greater than 470 milliseconds that cannot be corrected with electrolyte replacement, hydration, or medication modification. This criterion does not apply to participants with a pacemaker.","ALL","18 Years",{"count":19,"type":20},84,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This Phase 1, open-label, multicenter study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade B-cell lymphomas.\n\nThe study has two sequential parts. Part 1 uses dose escalation to determine the biologically effective dose and\u002For maximum tolerated dose of lonitoclax. Participants receive a 3-day step-up regimen followed by continuous once-daily or twice-daily oral dosing in 28-day cycles. Part 2 is a randomized dose-expansion comparison of two selected lonitoclax dose levels in venetoclax-naive participants with relapsed or refractory CLL\u002FSLL. Treatment may continue for up to 12 cycles and, for participants deriving clinical benefit, for up to 24 cycles with approval from the Medical Monitor.",[26,27,28,29,30],"CLL \u002F SLL","CLL (Chronic Lymphocytic Leukemia)","SLL (Small Lymphocytic Lymphoma)","Marginal Zone Lymphoma(MZL)","Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia",[32,33,34,35,36,37,38,39,40,41],"Lonitoclax","ZE50-0134","BCL2 inhibitor","relapsed or refractory","dose escalation","dose expansion","dose optimization","BTK inhibitor","venetoclax","tumor lysis syndrome","RECRUITING","2026-07-30",{"date":45,"type":46},"2026-07-31","ACTUAL",{"date":48,"type":46},"2025-04-08",{"date":50,"type":20},"2028-07",{"name":52,"class":53},"Lomond Therapeutics Holdings, Inc.","INDUSTRY",5,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100544277","phase-1-dose-escalation-and-expansion-study-to-evaluate-the-safety-pk-pd-and-efficacy-of-ze46-0134-in-adults-with-flt3-mutated-or-spliceosome-mutated-relapsed-or-refractory-acute-myeloid-leukemia-100544277","NCT06366789","Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.\n5. For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening period 28 days) prior to study drug administration on C1D1 if therapy has been given.\n5. Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion criteria\n\n1. Diagnosis of isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML)\n2. Acute promyelocytic leukemia (FAB M3)\n3. Active central nervous system (CNS) involvement by AML\n4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy\n5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy\n6. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the local regulatory authority.\n8. Systemic antineoplastic therapy within 5 half-lives or radiation therapy within 1 week prior to starting protocol with the exception of hydroxyurea, which is allowed to control white blood cell counts.\n9. Female patients who are pregnant or lactating\n10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n11. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction), New York Heart Association (NYHA) Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n12. Infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control in the opinion of the Investigator. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.",{"count":63,"type":20},150,[23],"This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia",[67],"AML With Gene Mutations","2025-12-24",{"date":70,"type":46},"2025-12-31",{"date":72,"type":46},"2024-05-29",{"date":74,"type":20},"2027-12",{"name":52,"class":53},23,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100616288","phase-1-a-phase-1b-study-of-lonitoclax--azacitidine-in-acute-myeloid-leukemia-patients-100616288","NCT07303660","A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients","A Phase 1b Study of Lonitoclax + Azacitidine (Aza) in Acute Myeloid Leukemia (AML) Patients","Inclusion Criteria:\n\n1\\. Patients must be able to understand and provide written informed consent. 2. AML patients: For the dose escalation and expansion, patients aged 18 and older with relapsed and\u002For refractory AML would be eligible. Prior treatment with a hypomethylating agent or Venetoclax is allowed.\n\n3\\. At the time of Lonitoclax initiation, white blood count (WBC) needs to be \\\u003C 25 × 109\u002FL: Hydroxyurea can be used to achieve that level.\n\n4\\. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 5. Adequate organ function as defined by the following:\n\n1. Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN. AST and\u002For ALT may be up to 5 x ULN if thought to be secondary to leukemia.\n2. Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert's syndrome may enroll if direct bilirubin is ≤ 3 x ULN) for the local laboratory.\n3. Estimated Glomerular Filtration Rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) ≥ 60 mL\u002Fmin\u002F1.73m2 for the local laboratory.\n\n   6\\. Female patients of childbearing potential must agree to use a highly effective method of contraception from screening visit until 120 days following the last dose of study treatment. Highly effective methods of contraception include sexual abstinence, bilateral tubal ligation, tricycle combined (estrogen and progestogen containing) oral or transdermal hormonal contraceptives, intrauterine devices and vasectomized partner. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n\n   7\\. Male patients capable of having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use highly effective contraception from the screening visit until 120 days until the last dose of study treatment, and themselves use barrier contraception (i.e., condoms). They must also refrain from sperm donation from the screening visit until 120 days following the last dose of study treatment. Should his partner become pregnant or suspect she is pregnant while he is participating in this study, he should inform his treating physician immediately.\n\n   8\\. Patients must be able to take oral medications. Exclusion Criteria\n   1. Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML).\n   2. Acute promyelocytic leukemia (FAB M3).\n   3. Active central nervous system (CNS) involvement by AML.\n   4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy.\n   5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n   6. Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n   7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by Regulatory Authorities.\n   8. Systemic antineoplastic therapy within 1 week (or 5 half-lives of drug received, whichever is shorter) or radiation therapy within 1 week prior to starting protocol except for hydroxyurea, which is allowed to control white blood cell counts.\n   9. Female patients who are pregnant or lactating.\n   10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.\n   11. Concomitant medications that are strong CYP3A4 inducers.\n   12. Patients with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications. This does not apply to patients with a pacemaker as measurement of QTc is not accurate under such conditions and bears no risk to patients since they are being medically paced by their device.\n   13. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin leak alone not included if no residual dysfunction), familial QT prolongation, known potassium wasting syndrome (Bartter syndrome, Gitelman syndrome, and Liddle syndrome), New York Heart Association (NYHA) Class III or IV heart failure, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n   14. As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.\n\n   Exclusion Criteria:\n   1. Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML).\n   2. Acute promyelocytic leukemia (FAB M3).\n   3. Active central nervous system (CNS) involvement by AML.\n   4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy.\n   5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n   6. Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n   7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by Regulatory Authorities.\n   8. Systemic antineoplastic therapy within 1 week (or 5 half-lives of drug received, whichever is shorter) or radiation therapy within 1 week prior to starting protocol except for hydroxyurea, which is allowed to control white blood cell counts.\n   9. Female patients who are pregnant or lactating.\n   10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.\n   11. Concomitant medications that are strong CYP3A4 inducers.\n   12. Patients with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications. This does not apply to patients with a pacemaker as measurement of QTc is not accurate under such conditions and bears no risk to patients since they are being medically paced by their device.\n   13. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin leak alone not included if no residual dysfunction), familial QT prolongation, known potassium wasting syndrome (Bartter syndrome, Gitelman syndrome, and Liddle syndrome), New York Heart Association (NYHA) Class III or IV heart failure, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n   14. As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.",{"count":85,"type":20},66,[23],"This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory Acute Myeloid Leukemia patients.",[89],"Acute Myeloid Leukemia",[89,91],"AML","NOT_YET_RECRUITING","2025-12-18",{"date":95,"type":46},"2025-12-26",{"date":97,"type":20},"2026-01-10",{"date":99,"type":20},"2027-11",{"name":52,"class":53},""]