[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Uma Borate\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,93],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100533189","phase-1-sndx-5613-and-gilteritinib-for-the-treatment-of-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-and-concurrent-mll-rearrangement-or-npm1-mutation-100533189",false,"NCT06222580","SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation","Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed\u002FRefractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:\n\n  * Relapsed or Refractory Acute Myeloid Leukemia with the following:\n\n    * Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and\u002For reappearance of peripheral blasts\n  * FLT-3 mutated disease of the ITD or TKD subtype, AND\n  * NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)\n* Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors\u002Finducers\n* Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)\n* Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan\n* Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment\n* Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment\n* Must be able to swallow the study medications\n* Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia\n* Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:\n\n  * Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and\u002For ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)\n  * Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)\n  * Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy\n  * Antileukemia Therapy\\*\\*\\*: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n  * Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator\n  * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion\n  * Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors\n  * Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent\n  * Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg\u002Fm\\^2 \u002Fday for patients\n\n    * Prior treatment with gilteritinib is allowed\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma\n* Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient\n* Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Fridericia's corrected QT interval (QTcF) \\> 450 msec at time of screening\n* Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\n* Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure\n* Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee\n* Any psychiatric illness that prevents patient from informed consent process\n* Pregnant or breastfeeding at the time of enrollment\n* Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration\n* Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study or interpretation of study results","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and\u002For effective in treating patients with relapsed\u002Frefractory FLT3 mutated acute myeloid leukemia.",[26,27,28,29,30],"Acute Myeloid Leukemia With FLT3\u002FITD Mutation","Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","RECRUITING","2026-05-12",{"date":34,"type":35},"2026-05-14","ACTUAL",{"date":37,"type":35},"2024-02-20",{"date":39,"type":20},"2027-02-28",{"name":41,"class":42},"Uma Borate","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100587589","phase-2-ziftomenib-for-the-treatment-of-patients-with-npm1-mutated-or-kmt2a-rearranged-acute-myeloid-leukemia-not-eligible-for-standard-therapy-100587589","NCT06930352","Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy","Frontline Ziftomenib in NPM1-Mutated or KMT2A-Rearranged Acute Myeloid Leukemia in Patients Not Eligible for Intensive Induction or Other Therapy","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) Classification:\n\n  * Treatment-naïve acute myeloid leukemia\n  * KMT2A rearrangement (defined as KMT2A translocations) OR NPM1 mutation (defined as NPM1 mutation resulting in cytoplasmic localization, or NPM1c) OR other mutations that have been shown to exhibit sensitivity to menin inhibition. Mutation status will be known from initial diagnosis using standard of care testing, which can be performed locally\n* Patients ineligible or unwilling to receive standard of care induction therapy, such as 7+3, hypomethylating agent, venetoclax, or other standard of care (SOC) regimens with ineligibility defined by the following:\n\n  * ≥ 75 years of age with both of the following;\n\n    * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection\n    * Subject must have adequate liver function as demonstrated by aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (unless considered due to leukemic organ involvement) OR\n  * ≥ 18 to 74 years of age with at least one of the following co-morbidities:\n\n    * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3;\n    * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina;\n    * Diffusion capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%;\n    * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin;\n    * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 x ULN;\n    * Venous thromboembolism benefitting from prolonged anticoagulation or presence of prosthetic heart valve or any indication for therapeutic anticoagulation with a single agent\n    * Prior history of severe infection requiring hospitalization with risk of recurrence with subsequent immunosuppression\n    * Any other comorbidity that the physician judges to be incompatible with standard frontline therapy must be reviewed and approved by the study team before study enrollment\n* Peripheral white blood cell (WBC) counts ≤ 10,000\u002FuL. Patients may receive hydroxyurea, cytarabine, or leukapheresis to control and maintain white blood cell count until the end of cycle 1\n* Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 180 days after the last dose of study treatment\n* Non-sterile male patients must agree to use a highly effective method of contraception with partner(s) throughout the study and for at least 90 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of chronic myelogenous leukemia in blast crisis\n* Clinically active central nervous system (CNS) leukemia\n* Prior treatment for AML except for hydroxyurea and\u002For cytarabine used for control of leukocytosis\n* Treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450-isozyme 3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient\n* Detectable viral load for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen indicative of active infection. Patients with controlled disease will not be excluded from study enrollment\n* Pre-existing disorder predisposing the patient to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to AML)\n* Active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection\n* Mean Fridericia's formula-corrected QT interval (QTcF) \\> 480 ms on triplicate electrocardiogram (ECG)\n* Any psychiatric illness that prevents patient from informed consent process\n* Women who are pregnant or lactating. All female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to starting treatment\n* Participants requiring dual antiplatelet therapy",{"count":51,"type":20},70,[53],"PHASE2","This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.",[56],"Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-03-11",{"date":60,"type":35},"2026-03-13",{"date":62,"type":20},"2026-04-10",{"date":64,"type":20},"2027-12-31",{"name":41,"class":42},1,{"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":77,"conditions":78,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":66},"100556319","phase-1-axatilimab-with-or-without-azacitidine-for-the-treatment-of-patients-with-advanced-phase-myeloproliferative-neoplasms-myeloproliferative-neoplasmmyelodysplastic-syndrome-overlap-or-high-risk-chronic-myelomonocytic-leukemia-100556319","NCT06523556","Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm\u002FMyelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia","Phase 1b\u002F2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN\u002FMDS Overlap or High-Risk CMML","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2016 World Health Organization (WHO) classification (Arber et al 2016): Phase 1b, patients with relapsed or refractory of any of the following; phase 2, patients with newly diagnosed of any of the following:\n\n  * Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model\n  * Atypical chronic myelocytic leukemia (aCML)\n  * MDS\u002FMPN unclassified (MDS\u002FMPN-U)\n  * Myeloproliferative neoplasm accelerated phase (MPN-AP)\n  * MPN-AP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) with intermediate-2 or high risk disease according to International Prostate Symptom Score (IPSS) as well as progression on or failure to respond to at least one line of therapy.\n  * Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T) or MDS\u002FMPN with SF3B1 mutation and thrombocytosis (MDS\u002FMPN-SF3B1-T).\n  * Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease \\[MDRD\\] formula, by local laboratory)\n* Patient is able to communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Women of childbearing potential and men, if not surgically sterilized, should use adequate contraception from 14 days prior to study entry and until 90 days after the last follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom\n\nExclusion Criteria:\n\n* Previous treatment for MPN or MDS\u002FMPN overlap with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 2 cycles of hypomethylating agents \\[HMAs\\] can be included). However, previous treatment with hydroxyurea and\u002For ruxolitinib is permitted\n* Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)\n* Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment\n* History of organ transplant or allogenic hematopoietic stem cell transplant\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study.\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of axatilimab\n* History of acute or chronic pancreatitis\n* History of myositis",{"count":75,"type":20},52,[23,53],"This phase Ib\u002FII trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm\u002Fmyelodysplastic syndrome (MPN\u002FMDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN\u002FMDS overlap or high risk CMML.",[79,80,81,82,83,84,85,86],"Atypical Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Myeloproliferative Neoplasm","Refractory Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myeloproliferative Neoplasm",{"date":60,"type":35},{"date":89,"type":35},"2024-08-02",{"date":91,"type":20},"2028-10-31",{"name":41,"class":42},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100488570","phase-2-canakinumab-for-the-prevention-of-progression-to-cancer-in-patients-with-clonal-cytopenias-of-unknown-significance-impact-study-100488570","NCT05641831","Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study","A Randomized Double-Blind Placebo-Controlled Phase II Multi-Center Study of Inflammation Modification of Canakinumab to Prevent Leukemic Progression of Clonal Cytopenias of Unknown Significance (CCUS): IMPACT Study","Inclusion Criteria:\n\n* Patients with age \\>= 18 with high-risk CCUS\n* Must meet ALL the following criteria:\n\n  * Unexplained, clinically meaningful cytopenias (greater than 4 months) in one or more of the following lineages: erythroid cells, neutrophils, platelets. Clinically meaningful cytopenia is institution specific and threshold may vary on age, sex, and race. Decision-making should depend upon lab values specific to the institution and supersede public works. Based upon published work, significant cytopenias are defined as the following (must meet criteria in at least one lineage):\n\n    * Erythroid Cells:\n\n      * Hemoglobin \\\u003C 11 g\u002FdL\n    * White Blood Cells:\n\n      * Absolute Neutrophil Count \\\u003C 1800\u002FmicroL and \\> 500\u002FmicroL\n    * Platelets:\n\n      * Platelet Count \\\u003C 150,000\u002FmicroL and \\> 50,000\u002FmicroL\n  * MDS criteria not fulfilled\n  * No other evidence of hematological malignancy\n  * No or only mild (\\\u003C 10%) bone marrow dysplasia\n  * Blast cells \\\u003C 5% detected via morphologic examination of blood and\u002For bone marrow smears which can also be supported by flow cytometry and\u002For immunohistochemical studies\n  * Any of the following:\n\n    * Isolated somatic spliceosome mutation at any VAF (SRSF2, SF3B1, U2AF1, or ZRSR2)\n    * Isolated TP53 mutation greater than 5% VAF\n    * At least 1 mutation in TET2, DMNT3A, or ASXL1 at any VAF coupled with at least 1 other known myeloid pathogenic somatic mutation or known pathogenic germline mutation that predisposes to myeloid malignancy as determined by next generation sequencing and bone marrow biopsy\n    * A TET2, DMNT3A, or ASXL1 greater than 10% VAF coupled with another TET2, DMNT3A, or ASXL1 greater than 10% VAF\n    * The presence of two or more known myeloid pathogenic somatic or germline mutations (other than TET2, ASXL1, DMNT3A, TP53, or spliceosome mutations) greater than 10% VAF\n* Ability to understand and willingness to sign the written informed consent document\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Patients with a history of hypertension or active hypertension are strongly encouraged to optimize blood pressure control\n* Creatinine clearance greater than 45 ml\u002Fmin using Cockcroft-Gault\n* Total bilirubin =\\\u003C 1.5 x ULN\n* Aspartate transaminase (AST) \\\u003C 3 x ULN\n* Alanine transaminase (ALT) \\\u003C 3 x ULN\n\nExclusion Criteria:\n\n* Concurrent malignancy requiring active systemic therapy\n* Diagnosis of MDS or any other myeloid malignancy in the patient's lifetime\n* History of Hypersensitivity to canakinumab or drug of a similar class\n* Active infection requiring prompt evaluation and treatment or history of recurrent infections\n* Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (via positive or indeterminate central laboratory \\[lab\\] results)\n* Subjects with active tuberculosis. In subjects with a history of tuberculosis but without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or Institutional Review Board (IRB) in which case curative treatment must be completed prior to screening)\n* Subjects with suspected or proven immunocompromised state or infections. If the results of this screening per local treatment guidelines or clinical practice require treatment for said infection then the patient is not eligible. Suspected or proven immunocompromised states or infections include:\n\n  * Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy. If in the opinion of the investigator, the patient's immunocompromised state does not pose an unacceptable risk for participation, in the absence of uncontrolled infection, and the patient does not have a history of serious infections (such as tuberculosis); then the patient may participate in this study.\n  * Known history of testing positive for human immunodeficiency virus (HIV) infections. For countries where HIV status is mandatory: testing positive for HIV during screening using a local test.\n  * Allogeneic bone marrow or solid organ transplant (history of any or within a certain period of time?)\n  * Those requiring systemic or local treatment in doses with systemic effects e.g.:\n\n    * Prednisone \\> 20 mg (or equivalent) oral or intravenous daily for \\> 14 days\n    * Prednisone \\> 5 mg and =\\\u003C 20 mg (or equivalent) daily for \\> 30 days\n    * Equivalent dose of methotrexate \\> 15 mg weekly\n    * Note: Azathioprine is allowed. Daily glucocorticoid-replacement for conditions such as adrenal or pituitary insufficiency is allowed. Topical, inhaled or local steroid use in doses that are not considered to cause systemic effects are permitted. Steroids for pre-medication related to chemotherapy as per local standard of care are permitted.\n* Live or attenuated vaccination within 3 months prior to first dose of study drug (e.g. Measles\u002FMumps\u002FRubella \\[MMR\\], Yellow Fever, Rotavirus, Smallpox, etc.) and after initiation of canakinumab treatment\n* Use of erythropoietin stimulating agents (ESA) or growth factors within four weeks prior to the start of the study\n* Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment and for up to 130 days after last dose of study drug. Basic contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject\n  * Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n  * Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Prior to entry into this study, cisplatin-based chemotherapy, which may be toxic to the fetus, may be given. The time between the end of cisplatin-based chemotherapy and the start canakinumab\u002Fplacebo treatment is variable, resulting in a variable need for continuation of highly effective contraception. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks prior to first dose of study drug. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the Informed Consent Form (ICF).",{"count":101,"type":20},110,[53],"This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).",[105],"Clonal Cytopenia of Undetermined Significance","2025-12-31",{"date":108,"type":35},"2026-01-02",{"date":110,"type":35},"2023-02-06",{"date":112,"type":20},"2028-12-31",{"name":41,"class":42},6,""]