[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-monocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-monocytic-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,108],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100554851","phase-2-venetoclax-in-combination-with-cladribine-and-cytarabine-alternating-with-azacitidine-plus-venetoclax-for-the-treatment-of-newly-diagnosed-monocytic-aml-and-active-signaling-mutated-aml-100554851",false,"NCT06504459","Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML","A Phase II Study of Venetoclax (ABT-199) in Combination With Cladribine and Low-Dose Cytarabine Alternating With Azacitidine Plus Venetoclax in Newly Diagnosed Monocytic AML and Active-Signaling Mutated AML","Inclusion Criteria:\n\n* Ability to comprehend the investigational nature of the study and provide informed consent (i.e., participant or legally authorized representative \\[LAR\\]). Written informed consent must be obtained prior to any study-specific procedures or interventions\n\n  • Sign informed consent for the #4422 Biorepository prior to any study-specific procedures of interventions\n* Eligible AML patients of all races and ethnic groups will be considered for participation, irrespective of gender identity\n* Newly diagnosed, histologically confirmed monocytic AML, as defined by World Health Organization (WHO), or active signaling mutated AML defined as AML with mutation(s) to N\u002FKRAS, FLT3 ITD\u002FTKD, NF1, PTPN11 or CBL\n* Ineligible for standard of care induction therapy using intensive chemotherapy (IC) or unwilling to undergo IC induction therapy. Ineligible for IC is defined as\n\n  * ≥ 75 yrs of age; OR\n  * 18-74 yrs of age with one of the following:\n\n    * Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 at screening\n    * Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)\n    * Severe pulmonary disorder (e.g., diffuse capacity of the lung for carbon monoxide \\[DLCO\\] ≤ 65% or forced expiratory volume in 1 second \\[FEV1\\] ≤ 65%)\n    * Creatinine clearance \\\u003C 45 ml\u002Fmin (calculated by the Cockcroft-Gault equation)\n    * Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal (ULN)\n    * Any other comorbidity that the treating physician judges to be incompatible with IC\n* If ≥ 75 yrs of age, the following organ function values must be met and ECOG must be 0 to 2 at screening:\n\n  * Creatinine clearance (calculated with the Cockcroft-Gault equation) ≥ 30 ml\u002Fmin\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Unless due to leukemic infiltration)\n  * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x ULN (Unless due to leukemic infiltration) (With the exception of documented Gilbert's syndrome or similar conditions. Liver function testing (LFT) and timepoints may be added, as clinically indicated, in such cases)\n\n    * Note: In cases of confirmed leukemic organ involvement, exceptions may be made\n* Willing and able to provide bone marrow (BM) samples, including BM samples for research use only analysis\n* Willing and able to accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequalae\n* Willingness to adhere to (a) study schedule of activities; (b) requirements for bio samples collections; and (b) lifestyle restrictions while on-treatment\n* Negative urine pregnancy test at screening and within 24 hours of cycle 1 day 1 (C1D1) for persons of childbearing potential (PCBP). Serum pregnancy testing will be used for confirmation in cases of equivocal results. Pregnancy is exclusionary because the agents used in this study have the potential for teratogenic or abortifacient effects\n* Willingness to comply with study requirements for contraception within the specified timeframe, as follows:\n\n  * Sperm producing participants who are active with PCBP must use approved contraception from C1D1 to 30 days, 3 months, or 6 months, after the last dose of venetoclax (30 days), azacitidine (3 months), cladribine (6 months), or cytarabine (6 months), whichever is later in time\n  * PCBP who are sexually active with sperm-producing persons must use contraception from C1D1 to 30 days after the last dose of venetoclax or to 6 months after the last dose of azacitidine, cladribine, or cytarabine, whichever is later in time\n\nExclusion Criteria:\n\n* Symptomatic central nervous system involvement with AML\n* Prior treatment for AML, with the exception of cytoreduction for proliferative disease (per institutional protocol) with any of the following: Hydroxyurea, hematopoietic growth factors, leukapheresis\n* Another active malignancy within the previous 5 years of C1D1\n* Investigational therapy within 28 days of C1D1, or within 5 half-lives or longer, if known\n* Recent and significant medical interventions, such as major surgery within 28 days or stem cell transplant within 100 days (and without active treatment for graft versus host disease \\[GVHD\\]) of C1D1. Standard of care procedures for patients with hematologic malignancies, such as biopsies and lumbar punctures, are not exclusionary\n* Hypersensitivity to any of the components of the investigational regimen (i.e., cladribine, cytarabine, venetoclax, azacitidine) or any excipients in the formulations\n* Treatment based on agents targeting or inhibiting BCL-2 (for other, prior indication\u002Fmalignancy) within the previous 5 years\n* History of dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally\n* Use of drugs with documented drug-drug interaction toxicities with the study drugs\n\n  * Strong or moderate CYP3A4 inducers or inhibitors within 2 days or 3 half lives whichever is longer, prior to C1D1 are exclusionary. Dose adjustments and other modifications may be considered if the wash-out period has not been met, with the approval of the investigator and the research pharmacy\n* Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to C1D1 and must be amenable to alternate treatment if current treatment will interact with investigational regimen\n* Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Enrollment of individuals with evidence of chronic HBV or HCV infection will be considered on a case-by-case basis by the principal investigator\n* Individuals with serology positive for human immunodeficiency virus (HIV) and under active treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents)\n* Pregnancy at enrollment or unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding be discontinued from start of treatment until 1 week after the final dose of any study drug\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, unstable cardiac or pulmonary function or acute insufficiency (e.g., symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), or psychiatric illness or social situation that could limit compliance with study requirements","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.",[26,27],"Acute Monocytic Leukemia","Acute Myeloid Leukemia","RECRUITING","2026-04-07",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":32},"2025-01-03",{"date":36,"type":20},"2028-05-01",{"name":38,"class":39},"OHSU Knight Cancer Institute","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100632362","phase-2-venetoclax-combined-with-cacag-regimen-versus-37-regimen-in-the-treatment-of-acute-monocytic-leukemia-100632362","NCT07512700","Venetoclax Combined With CACAG Regimen Versus \"3+7\" Regimen in the Treatment of Acute Monocytic Leukemia","Venetoclax Combined With CACAG Regimen Versus \"3+7\" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study","Inclusion Criteria:\n\n* Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.\n* Age 14 to 60 years at screening, no gender restriction.\n* Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.\n* No history of severe allergic reactions.\n* Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.\n* Renal function: serum creatinine ≤ 1.5 × ULN\n* No uncontrolled infection or severe psychiatric disorder.\n* ECOG performance status 0-3; life expectancy ≥ 4 months.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to any study drug.\n* Pregnancy or lactation.\n* Active infection.\n* Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.\n* Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.\n* Major organ surgery within 6 weeks prior to enrollment.\n* Abnormal liver function: total bilirubin \\> 2× ULN, ALT\u002FAST \\> 2.5 × ULN; abnormal renal function: serum creatinine \\> 1.5 × ULN.\n* Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).","14 Years","60 Years",{"count":51,"type":20},204,[23],"This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.",[26],[26,56],"Venetoclax+CACAG","2026-04-02",{"date":59,"type":32},"2026-04-06",{"date":61,"type":32},"2025-09-01",{"date":63,"type":20},"2029-10-31",{"name":65,"class":39},"Chinese PLA General Hospital",3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":90,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100589101","phase-1-a-phase-1-study-of-stx-0712-in-patients-with-advanced-hematological-malignancies-cmml-and-aml-100589101","NCT06950034","A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)","A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies","Inclusion Criteria:\n\n* Refractory\u002Fresistant CMML, defined as: Diagnosis of CMML 1 or 2; and has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease OR\n* Relapsed\u002Frefractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and\u002For monocytic precursors (promonocytes\u002Fmonoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \\\u003C30,000\u002FµL (microliters) and \\\u003C20% circulating blasts.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n* Life expectancy of \\>2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator.\n* Adequate organ function.\n* Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion.\n* Able to understand and willing to sign a written informed consent form.\n* Willing and able to comply with study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap syndromes other than CMML. For AML: Acute Promyelocytic Leukemia (APL) or Isolated extramedullary disease.\n* Eligible for an immediate allogenic stem cell transplant (alloSCT).\n* Current active use of nicotine products including tobacco, nicotine patches or vaping products.\n* Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.\n* Has active autoimmune condition requiring immunosuppressive treatment or is receiving immunosuppressive therapy for the treatment of autoimmune disorders, allergies, or other clinical symptoms. Systemic steroids \\\u003C10 mg (milligrams) daily of prednisone equivalent are allowed; and intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids are allowed.\n* Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and AML participants, hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712. Hydroxyurea will also be permitted for first cycle of STX-0712 treatment for participants with proliferative CMML or AML with high white blood count (WBC ≥25,000\u002FµL).\n* Received an investigational treatment within 30 days prior to dosing with STX-0712.\n* Received Granulocyte Colony Stimulating Factor \\[G-CSF\\], Granulocyte Macrophage Colony Stimulating Factor \\[GM-CSF\\], erythropoietin, romiplostim, or other growth factors within 2 weeks prior to first dose of STX- 0712.\n* Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712.\n* Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled or unstable chest pain, history of heart attack(s), or stroke within 6 months prior to consent, uncontrolled high blood pressure, or clinically significant arrhythmias not controlled by medication).\n* QT interval corrected by Fridericia's formula (QTcF) \\>470 msec for both men and women on Screening electrocardiogram(s) (ECG). Patients with a bundle branch block must have QT interval corrected for bundle branch block.\n* Other than AML or CMML, active malignancy and\u002For cancer history that requires active therapy. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.\n* Active, uncontrolled bacterial, fungal, or viral infection.\n* Known human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Evidence of any other severe or uncontrolled systemic diseases, any other serious and\u002For unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.",{"count":75,"type":20},105,[77],"PHASE1","This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.",[80,81,82,83,84,85,27,86,87,88,89,26],"Chronic Myelomonocytic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Chronic Myelomonocytic Leukemia-1","Chronic Myelomonocytic Leukemia-2","Refractory Chronic Myelomonocytic Leukemia","CMML","Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemias","Refractory Acute Myeloid Leukemia (AML)",[91,85,92,93,94,95,80,27,84,96],"refractory\u002Fresistant CMML","AML","monocytic AML","Relapsed\u002Frefractory AML","monocytic-predominant AML","Refractory Acute Myeloid Leukemia","2026-02-05",{"date":99,"type":32},"2026-02-09",{"date":101,"type":32},"2025-03-13",{"date":103,"type":20},"2027-06-30",{"name":105,"class":106},"Solu Therapeutics, Inc","INDUSTRY",7,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100482747","phase-2-venetoclax-and-azacitidine-combined-with-chidamide-vac-for-the-treatment-of-newly-diagnosed-acute-monocytic-leukemia-100482747","NCT05566054","Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia","A Multicenter, Randomized, Controlled Clinical Trial of Venetoclax, Azacytidine Combined With Chidamide for the Treatment of Newly Diagnosed Acute Monocytic Leukemia Patients That Are Ineligible for Intensive Chemotherapy","Inclusion Criteria:\n\nConfirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and\u002For characterized for expression of monocytic and myeloid differentiation markers, have a projected life expectancy of at least 12 weeks, previously untreated, and ineligible for treatment with intensive chemotherapy.\n\nPatients must be considered ineligible for induction therapy defined by the following:\n\n1. \\>= 60 years of age\n2. \\>=18 to 59years of age with at least one of the following comorbidities:\n\n   Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy:\n\n   (A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. (B)Cardiac history of congestive heart failure requiring treatment or ejection fraction \\\u003C= 50% or chronic stable angina.\n\n   (C)Diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C= 65% or forced expiratory volume during the first second (FEV1) \\\u003C= 65%.\n\n   (D)Creatinine clearance \\>= 30 mL\u002Fmin to \\\u003C 45 mL\u002Fmin. (E)Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C= 3.0 × upper limit of normal (ULN).\n3. Must meet the laboratory requirements per the protocol.\n4. Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 90 days after the last dose of study drug.\n5. Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.\n6. Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment;\n7. Other comorbidities that are not suitable for intensive chemotherapy;\n8. The patient refused to receive intensive chemotherapy;\n9. Ability to understand and willing to sign the informed consent for this trial.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception\n3. Active infection\n4. Active bleeding\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met\n7. Liver function abnormalities (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value)\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment\n9. Urgery on the main organs within the past six weeks\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results\n11. Patients who have received organ transplants (excepting bone marrow transplantation)\n12. Patients not suitable for the study according to the investigator's assessment",{"count":116,"type":20},92,[23],"This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy",[26,120],"Newly Diagnosed",[122,123,124],"Chidamide","Azacitidine","Venetoclax","2025-11-18",{"date":127,"type":32},"2025-11-21",{"date":129,"type":32},"2022-03-01",{"date":131,"type":20},"2026-09-30",{"name":133,"class":39},"The First Affiliated Hospital of Soochow University",1]