[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloid-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloid-sarcoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,96,121],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100331014","phase-2-dexrazoxane-hydrochloride-in-preventing-heart-related-side-effects-of-chemotherapy-in-participants-with-blood-cancers-100331014",false,"NCT03589729","Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers","Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.\n* Patients of child bearing potential should use contraception.\n* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.\n* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.\n* Patients with myeloproliferative neoplasms in blast phase will be eligible.\n* Patients with isolated extramedullary myeloid neoplasm will be eligible.\n* Patients with active CNS (central nervous system) disease are eligible.\n* Bilirubin \\\u003C 2mg\u002FdL.\n* AST (aspartate aminotransferase) and\u002For ALT (alanine aminotransferase) \\\u003C 3 x ULN (upper limit of normal) - or \\\u003C 5 x ULN if related to leukemic involvement.\n* Creatinine \\\u003C 1.5 x ULN.\n* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.\n* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).\n* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).\n* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.\n* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.\n* Decompensated heart failure (HF).\n* Clinically significant arrhythmias.\n* Severe valvular disease.\n* History of coronary artery disease (CAD).\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per the judgment of the investigator.\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n* Men and women of childbearing potential who do not practice contraception.","ALL","12 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.",[26,27,28,29,30,31,32],"Acute Myeloid Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Myeloid Sarcoma","Myeloproliferative Neoplasm","Philadelphia Chromosome Positive","RECRUITING","2026-05-19",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":37},"2018-09-19",{"date":41,"type":20},"2027-12-31",{"name":43,"class":44},"M.D. Anderson Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":68,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100495744","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-ziftomenib-in-combination-with-venetoclaxazacitidine-venetoclax-73-or-73quizartinib-in-patients-with-aml-100495744","NCT05735184","A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax\u002FAzacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML","Phase 1 Study of Venetoclax\u002FAzacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine\u002FDaunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed\u002Frefractory AML\n\n  * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate liver, renal, and cardiac function according to protocol defined criteria\n* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention\n\n  * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose\n\nKey Exclusion Criteria:\n\n* Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia\n* Known history of BCR-ABL alteration\n* Advanced malignant hepatic tumor\n* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or WBC \\> 25,000 \u002F microliter. Hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion\n* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia\n* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection\n* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia\n* For relapsed\u002Frefractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \\\u003C 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug\n* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol\n* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)\n\n  * Arm A and Arm B: \\>480 ms on triplicate ECGs\n  * Arm C: \\>450 ms on triplicate ECGs\n* Uncontrolled infection\n* Women who are pregnant or lactating\n* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled\u002Fprogressing\n* Patients who have active GVHD requiring \\>0.5 mg\u002Fkg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment","18 Years",{"count":55,"type":20},420,[57],"PHASE1","Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.\n\nThis protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.\n\nThe purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.",[26,60,61,62,63,64,65,66,30,67],"Mixed Lineage Leukemia Gene Mutation","Refractory AML","AML With Mutated NPM1","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, in Relapse","NPM1 Mutation","KMT2Ar","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,61,64,84],"Leukemia","Myeloid","AML","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Newly diagnosed AML","Untreated AML","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":87,"type":37},"2026-03-13",{"date":89,"type":37},"2023-07-18",{"date":91,"type":20},"2030-04",{"name":93,"class":94},"Kura Oncology, Inc.","INDUSTRY",44,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":45},"100595102","phase-2-vam-in-secondary-aml-aml-with-extramedullary-involvement-and-myeloid-sarcoma-100595102","NCT07028086","VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma","Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma","Inclusion Criteria:\n\n1. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)\n2. Age 18-65 years\n3. Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary\u002Fmyeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;\n4. Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%\n5. Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN\n6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2\n\nExclusion Criteria:\n\n1. Assessed as unfit- or frail-AML;\n2. Patients with a history or concurrent diagnosis of other malignancies requiring treatment\n3. Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)\n4. Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients\n5. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period\n6. Patients with a history of severe neurological or psychiatric disorders\n7. Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias\n8. Cerebrovascular events (including transient ischemic attacks), etc.\n9. Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded\n10. Subjects who have received strong or moderate CYP3A inducers\u002Finhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment\n11. Patients unable to take oral medications or with malabsorption syndrome\n12. Patients deemed by the investigator to be unsuitable for participation in the study","65 Years",{"count":105,"type":20},48,[23],"The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity.\n\nBuilding upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.",[26,30],[110,111,30],"Secondary AML","AML with Extramedullary Involvement","2025-07-04",{"date":114,"type":37},"2025-07-09",{"date":116,"type":37},"2025-06-20",{"date":118,"type":20},"2028-04",{"name":120,"class":44},"Ruijin Hospital",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100524659","intensive-conditioning-withthibufluara-c-in-allo-hsct-for-myeloid-malignancies-with-extramedullary-involvement-100524659","NCT06111612","Intensive Conditioning withTHI\u002FBu\u002FFlu\u002FAra-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement","Intensive Conditioning Regimen With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myeloid Malignancies With Extramedullary Involvement","Inclusion Criteria:\n\n1. Age between 18 and less than 55 years, regardless of gender.\n2. Criteria for myeloid tumors with extramedullary involvement:\n\n   1. AML (Acute Myeloid Leukemia) with at least one extramedullary lesion achieving hematological remission (CR1 or CR2) after induction therapy.\n   2. MDS (Myelodysplastic Syndrome) with at least one extramedullary lesion and bone marrow blast percentage ≥ 5% achieving hematological CR after treatment; CMML (Chronic Myelomonocytic Leukemia) with at least one extramedullary lesion (diagnosed according to WHO standards) achieving hematological CR after treatment.\n   3. Control and remission of extramedullary lesions, including those in the central nervous system, testes, skin, and other extramedullary tissues.\n   4. Granulocytic sarcoma with or without bone marrow involvement, and achieving remission after treatment.\n3. Patients must have a suitable hematopoietic stem cell donor:\n\n   1. Related donors must have at least 5\u002F10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.\n   2. Unrelated donors must have at least 8\u002F10 matches for HLA-A, -B, -C, -DQB1, and\n\n      * DRB1.\n4. Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2.\n5. ECOG (Eastern Cooperative Oncology Group) performance status: 0-2.\n6. Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:\n\n   1. Serum creatinine ≤ 1.5x ULN (the upper limit of normal).\n   2. Cardiac function: Ejection fraction ≥ 50%.\n   3. Baseline oxygen saturation \\> 92%.\n   4. Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN.\n   5. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.\n7. Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. History of malignancies other than myeloid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ.\n2. ECOG \\> 2.\n3. HCT-CI score ≥ 3.\n4. Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.\n5. Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection.\n6. Conditions requiring treatment such as grade 2 or higher seizures, paralysis, aphasia, recent severe cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.\n7. HIV-infected individuals.\n8. Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.\n\n   Patients at risk of HBV reactivation, are defined as those who are positive for hepatitis B surface antigen or core antibody without receiving antiviral therapy.\n9. Pregnant or breastfeeding women.\n10. Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.","55 Years",{"count":130,"type":20},50,"OBSERVATIONAL","This study is a multicenter, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an intensive conditioning regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of myeloid malignancies with extramedullary involvement. The conditioning regimen includes thiotepa at a dose of 5mg\u002Fkg\u002Fd from d -9 to d -8 (2 days), fludarabine at 30mg\u002Fm2\u002Fd from d -7 to d -3 (5 days), cytarabine at 1-1.5g\u002Fm2\u002Fd from d -7 to d -3 (5 days), and busulfan at 3.2mg\u002Fkg\u002Fd from d -5 to d -3 (3 days). Conditioning begins on day -9, and donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. If disease relapse is suspected during the follow-up period, bone marrow or extramedullary relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.",[26,134,135,30,136],"Myelodysplastic Neoplasm","Chronic Myelomonocytic Leukemia","Extramedullary Myeloid Tumor","2024-07-19",{"date":139,"type":37},"2024-07-22",{"date":141,"type":37},"2024-01-20",{"date":143,"type":20},"2027-01-01",{"name":145,"class":44},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine"]