[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"blasts-more-than-5-percent-of-bone-marrow-nucleated-cells\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:blasts-more-than-5-percent-of-bone-marrow-nucleated-cells":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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},"100354542","phase-1-cpx-351-in-treating-patients-with-relapsed-or-refractory-high-risk-myelodysplastic-syndrome-or-chronic-myelomonocytic-leukemia-100354542",false,"NCT03896269","CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia","Phase 1 Dose Escalation Study of CPX-351 for Patients With Int-2 or High Risk IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia After Failure to Hypomethylating Agents","Inclusion Criteria:\n\n* Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)\n* Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment\n* MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2\u002Fhigh risk with excess blasts \\> 5%, or with 10-19% bone marrow blasts\n* No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents\n* Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study\n* Total bilirubin \\\u003C 3 mg\u002FdL (will allow less than 5 x upper limit of normal \\[ULN\\] if Gilbert's at investigator's discretion)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum creatinine clearance \\> 30 mL\u002Fmin and no end\u002Fstage renal disease\n* Hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50 by echocardiogram or multigated acquisition (MUGA) scan\n* History of myocardial infarction within the last 6 months or unstable\u002Funcontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias\n* Uncontrolled infection not adequately responding to appropriate antibiotics\n* Female patients who are pregnant or lactating\n* Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study\n* Female patients with reproductive potential who have a positive urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening\n* Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment)\n* Prior cumulative anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent, or \\> 400 mg\u002Fm\\^2 in patients who received radiation therapy to the mediastinum","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, 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.",[26,27,28,29,30,31,32],"Blasts 10-19 Percent of Bone Marrow Nucleated Cells","Blasts More Than 5 Percent of Bone Marrow Nucleated Cells","High Risk Chronic Myelomonocytic Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Recurrent High Risk Myelodysplastic Syndrome","Refractory Chronic Myelomonocytic Leukemia","Refractory High Risk Myelodysplastic Syndrome","RECRUITING","2026-05-18",{"date":36,"type":37},"2026-05-20","ACTUAL",{"date":39,"type":37},"2019-05-14",{"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":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100366305","phase-1-vyxeos-for-re-induction-treatment-of-acute-myeloid-leukemia-patients-with-persistent-disease-after-induction-100366305","NCT04049539","Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction","Open-Label Phase 2 Trial of Vyxeos in Patients With Intermediate and High-Risk Acute Myeloid Leukemia Who Have Failed an Initial Cycle of Standard Cytarabine and Daunorubicin Chemotherapy","Inclusion Criteria:\n\n* Subject must be able to provide written informed consent\n* Patients must have a diagnosis of acute myeloid leukemia\n* Patients must have received standard induction chemotherapy (cytarabine 100-200mg\u002Fm2 by continuous infusion on days 1-7 and either daunorubicin 45-90mg\u002Fm2 or idarubicin 10-12mg\u002F m2 daily for 3 days during days 1-7) within the 14-33 days prior to starting trial treatment and have documented persistent disease (13-29 days from the start of 7+3 treatment). Patients who have received a 7+3 regimen utilizing gemtuzumab ozogamicin may enroll. Patients who received lower doses of the above agents due to appropriate adjustments for reduced renal or hepatic clearance may also enroll. Persistent disease will be defined as bone marrow cellularity of \\>10-20% and bone marrow blast percentage of \\>5-10% or clear evidence of immunophenotypically aberrant leukemia cells in the bone marrow. The final determination of persistent AML will be made by the treating physician, but must meet NCCN criteria for persistent disease1. Enrollment of patients with less than 20% cellularity or less than 10% blasts will require approval of the principal investigator. Patients who received concomitant treatment with another targeted therapy for AML that is FDA-approved for administration with 7+3 (e.g. midostaurin) may enroll and can continue to receive this treatment (according to the FDA-approved 7+3 re-induction dosing schedule) during Vyxeos treatment.\n* Patients must be deemed by the treating physician to be unlikely to achieve complete response (CR) without further therapy\n* Patients must be deemed by the treating physician to be able to tolerate intensive chemotherapy (similar to 7+3 chemotherapy)\n* Normal left ventricular ejection fraction (\\>= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography \\[MUGA\\]) and lifetime daunorubicin dose of less than 462mg\u002Fm\\^2 (including recent course of 7+3), or equivalent doses of another anthracycline medications. (This is 550mg\u002Fm\\^2 \\[maximum lifetime dose\\] minus 88mg\u002Fm\\^2 \\[planned dose of Vyxeos on study\\].)\n* Eastern Cooperative Oncology Group (ECOG) functional status of 0, 1, or 2\n* Aspartate aminotransferase (AST) \\\u003C 5 x upper limit of normal (ULN) for the local laboratory\n* Alanine aminotransferase (ALT) \\\u003C 5 x ULN for the local laboratory\n* Total bilirubin \\\u003C 1.5 x ULN (except for patients with known Gilbert?s syndrome) for the local laboratory\n* Calculated creatinine clearance (according to the Cockcroft-Gault equation) \\> 40 mL\u002Fmin OR serum creatinine \\\u003C 1.5 x the ULN for the local laboratory\n* Female patients of childbearing potential must agree to use two forms of contraception from screening visit until 6 months following the last dose of study treatment. Female patients must have a documented negative pregnancy test\n* Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use two forms of contraception from screening visit until 6 months after the last dose of study treatment. They must also refrain from sperm donation from screening visit until 6 months following the last dose of study treatment\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (or M3 AML)\n* Patients known to have core binding factor AML (defined as presence of t(8;21), inv(16), or other cytogenetically equivalent abnormalities)\n* Patients known to have inactivating mutations of TP53 or evidence of an absence of p53 protein activity as indicated by a monosomal karyotype. Monosomal karyotype will be defined as two or more monosomies (loss of an entire chromosome or the entire long arm of a chromosome \\[such as 7q-\\]) or a single monosomy in the setting of a complex karyotype. Patients with a complex karyotype without a monosomy are eligible to enroll\n* Patients that the treating physician does not feel are able to tolerate intensive chemotherapy\n* History of serious (\\>= grade 3) hypersensitivity reaction to cytarabine, daunorubicin, or any component of the formulation\n* Known Wilson's disease or other symptomatic abnormality of copper metabolism (laboratory screening is not required in the absence of clinical or historical evidence of Wilson's disease or other problems of copper metabolism)\n* Total lifetime daunorubicin dose of more than 462 mg\u002Fm\\^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications. (This is 550mg\u002Fm\\^2 maximum dose - 88mg\u002Fm\\^2 planned dose of Vyxeos on study.)\n* Pregnancy or inability to use highly effective method of contraception for 6 months following last dose of Vyxeos. Potentially fertile patients must have documented negative serum pregnancy test. Breastfeeding should be avoided for at least 14 days after the last dose Vyxeos\n* Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. As infection is a common feature of AML, patients with active infections are permitted to enroll provided that the infection is under control\n* Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the United States (US) Food and Drug Administration (FDA)\n* Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up\n* Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial\n* 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 within 6 months prior to enrollment, 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\n* Other malignancy currently requiring active therapy (except minor surgery for non-melanoma skin cancer and for hormonal\u002Fanti-hormonal treatment, e.g. in prostate or breast cancer)","75 Years",{"count":55,"type":20},28,[23,57],"PHASE2","This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, 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. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.",[27,60,61],"Persistent Disease","Refractory Acute Myeloid Leukemia","2026-04-02",{"date":64,"type":37},"2026-04-08",{"date":66,"type":37},"2021-01-29",{"date":68,"type":20},"2026-12-31",{"name":70,"class":44},"Ohio State University Comprehensive Cancer Center",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100347260","phase-2-ruxolitinib-in-treating-patients-with-hypereosinophilic-syndrome-or-primary-eosinophilic-disorders-100347260","NCT03801434","Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders","Phase 2 Study of Ruxolitinib in Idiopathic Hypereosinophilic Syndrome and Primary Eosinophilic Disorders","Inclusion Criteria:\n\n* Subject with idiopathic hypereosinophilic syndrome must meet the following:\n\n  * Has as at least 2 readings with an absolute eosinophil count \\>= 1,500\u002Fmm\\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).\n  * Dependent, intolerant or refractory to corticosteroids OR has relapsed\u002Frefractory disease to other therapy besides corticosteroids.\n  * Symptomatic from his\u002Fher disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or biopsy-proven). This can include skin, lung, cardiac, central nervous system, liver, or gastrointestinal (GI) involvement, or evidence of symptomatic hepatic or splenic enlargement.\n* Subject with lymphocyte-variant hypereosinophilia must meet the following\n\n  * Has at least 2 readings with an absolute eosinophil count \\>= 1,500\u002Fmm\\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).\n  * Dependent, intolerant or refractory to corticosteroids\\* OR has relapsed\u002Frefractory disease to other therapy besides corticosteroids.\n  * Symptomatic from his\u002Fher disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or biopsy-proven). This can include skin, lung, cardiac, central nervous system, liver, or GI involvement, or evidence of symptomatic hepatic or splenic enlargement\n  * Has abnormal T-lymphocyte immuno-phenotype by flow cytometry.\n* Subject with chronic eosinophilic leukemia, not otherwise specified (CEL,NOS) must meet the following\n\n  * Has at least 2 readings with an absolute eosinophil count \\>= 500\u002Fmm\\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).\n  * Newly-diagnosed OR receiving corticosteroids OR has relapsed\u002Frefractory disease to any therapy besides corticosteroids.\n  * Has increased blasts in the blood or bone marrow (\\> 5% and \\\u003C 20%), and\u002For a clonal cytogenetic or molecular abnormality\n\n    * Subjects with JAK2 mutations are included within this group.\n* Subject with JAK2-rearranged eosinophilic neoplasm must meet the following\n\n  * Has at least 2 readings with an absolute eosinophil count \\>= 500\u002Fmm\\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).\n  * Newly-diagnosed OR receiving corticosteroids OR has relapsed\u002Frefractory disease to any therapy besides corticosteroids.\n\n    * This group includes subjects with PCM1-JAK2, BCR-JAK2, ETV6-JAK2 or other JAK2 rearrangements.\n* If receiving corticosteroids, must be a stable dose for \\>= 28 days prior to Day 1 (unstable dosing not eligible).\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3.\n* Willing and able to review and execute informed consent (legally-authorized consent acceptable).\n\nExclusion Criteria:\n\n* Active life-threatening complication(s) from underlying eosinophilic disease (i.e., leukostasis; acute thromboembolic disease including central nervous system (CNS) involvement; severe pulmonary or cardiac dysfunction). Stabilization of acute, life-threatening eosinophil-related co-morbidities will allow enrollment of the patient.\n* World Health Organization (WHO)-defined myeloid neoplasm associated with eosinophilia other than CEL NOS and JAK2 rearranged neoplasms (e.g., myelodysplastic syndrome (MDS); myeloproliferative neoplasms (MPN); MDS\u002FMPN overlap disorders; and systemic mastocytosis (SM).\n* Reactive hypereosinophilia due to connective tissue disease, sarcoidosis or eosinophilic granulomatosis with polyangiitis.\n* Organ-restricted ?tissue? eosinophilia with the absence of peripheral eosinophilia in the blood.\n* Invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers.\n* Myeloid or lymphoid neoplasm with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1.\n* Anticipated to receive a hematopoietic stem cell transplant within the first 6 months of treatment on trial.\n* Major surgery within 4 weeks prior to entering the study.\n* Life expectancy of \\\u003C 6 months.\n* Known diagnosis of human immunodeficiency virus (HIV).\n* Known diagnosis of chronic active hepatitis B or C (viral testing is not required). Subjects with a known history of hepatitis B and\u002For C are allowed on trial if at the time of enrollment, the virus is not active and undetected (testing required if there is a known history), and such patients are not actively receiving antiviral treatment specific for hepatitis B and\u002For C.\n* Clinically serious infections requiring ongoing antibiotic therapy.\n* Parasitic infection diagnosed within 24 weeks prior to enrollment.\n* Platelet count =\\\u003C 25 x 10\\^9\u002FL at baseline.\n* Alanine aminotransferase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) \\> 4 x upper limit of normal (ULN) or direct bilirubin \\> 4 x ULN (if considered to be unrelated to the underlying eosinophilic disorder).\n* End-stage renal function (creatinine clearance \\[CrCl\\] \\\u003C 15 mL\u002Fmin or glomerular filtration rate \\[GFR\\] \\\u003C 15 mL\u002Fmin) regardless of whether hemodialysis is required.\n* Use of investigational or commercial therapies with the intent to treat the underlying eosinophilic disorder within 28 days of study start, including interferon; imatinib; alemtuzumab; cyclosporine; methotrexate; mepolizumab; benralizumab; or other antibody therapies.\n* Use of hydroxyurea within 7 days of study start.\n* Prior therapy with ruxolitinib or other JAK inhibitors.\n* Previous allergic reactions to JAK inhibitors or excipients.\n* Unwilling to commit to abstinence from heterosexual contact or agree to use and comply with highly effective contraception, 28 days prior to starting study drug, during the treatment period and for 12 weeks after discontinuation of study treatment.\n* Females of childbearing potential who have a positive pregnancy test (urine or serum) during screening period.",{"count":80,"type":20},10,[57],"This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.",[84,85,27,86,87,88,89,90,91,92,93,94],"BCR-JAK2 Fusion Protein Expression","Blasts 20 Percent or Less of Peripheral Blood White Cells","Blasts More Than 5 Percent of Peripheral Blood White Cells","Blasts Under 20 Percent of Bone Marrow Nucleated Cells","Chronic Eosinophilic Leukemia, Not Otherwise Specified","Eosinophilia","Hepatomegaly","Hypereosinophilic Syndrome","JAK2 Gene Mutation","Splenomegaly","TEL-JAK2 Fusion Protein Expression","2025-12-20",{"date":97,"type":37},"2025-12-23",{"date":99,"type":37},"2019-11-15",{"date":101,"type":20},"2028-12-30",{"name":103,"class":44},"William Shomali",4]