[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-myelodysplasticmyeloproliferative-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-myelodysplasticmyeloproliferative-neoplasm":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,95],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100481488","phase-1-onvansertib-for-the-treatment-of-recurrent-or-refractory-chronic-myelomonocytic-leukemia-and-myelodysplastic-syndromempn-overlap-neoplasms-100481488",false,"NCT05549661","Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome\u002FMPN Overlap Neoplasms","Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) and Myelodysplastic Syndrome\u002FMPN Overlap Neoplasms Relapsed\u002FRefractory or Intolerant to Available Therapies","Inclusion Criteria:\n\nPRE-REGISTRATION - INCLUSION CRITERIA:\n\n* Age \\>= 18 years\n* History of World Health Organization (WHO)-defined diagnosis of proliferative CMML (WBC count \\>= 13,000\u002Fmm\\^3 at time of diagnosis), or MDS\u002FMPN overlap neoplasm with WBC count \\>= 13,000\u002Fmm3 at time of diagnosis (atypical CML and MDS\u002FMPN-NOS).\n\n  * NOTE: Hydroxyurea or hypomethylating induced leukopenia does not preclude inclusion. Discussion of WBC \\\u003C 13,000\u002Fmm\\^3 due to treatment at the time of preregistration must be discussed with the Sponsor\u002FPrincipal Investigator\n* Relapsed\u002Frefractory following treatment with hydroxyurea; or at least 4 cycles of treatment with hypomethylating agents; or who are intolerant of treatment with either therapy. Note: Prior exposure to erythropoiesis stimulating agents is allowed. Hydroxyurea may continue for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the Sponsor\u002FPrincipal Investigator\n* Willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to provide mandatory bone marrow specimens for correlative research\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* Platelet count \\>= 20,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to pre-registration)\n\n  * NOTE: For platelet count \\\u003C 20,000\u002Fmm3 and in situations where the primary investigator deems the thrombocytopenia to be attributable to the underlying CMML, patients can be enrolled as long as they are able to achieve a platelet count of 20,000\u002Fmm3 with transfusional support\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (=\\\u003C 3 x ULN for patients with Gilbert's syndrome) (obtained =\\\u003C 14 days prior to pre-registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 14 days prior to pre-registration)\n* Estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002Fm\\^2 using one of the following methods (obtained =\\\u003C 14 days prior to pre-registration):\n\n  * Chronic Kidney Disease-Epidemiology Collaboration (CKDEPI) 2021 formula\n  * Corrected creatinine clearance via serum and 24-hour urine creatinine assessment\n  * Iothalamate\u002FIohexol glomerular filtrate rate via plasma\u002Furine assessment\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n\nREGISTRATION - INCLUSION CRITERIA:\n\n* Histological confirmation of WHO-defined diagnosis of a myelodysplastic\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) including one of the following (NOTE: to confirm patient is still eligible and has not progressed to\n\nAML):\n\n* Proliferative CMML\n* Atypical chronic myeoloid leukemia (aCML)\n* MDS\u002FMPN not otherwise specified (MDS\u002FMPN, NOS)\n* NOTE: Hydroxyurea or hypomethylating agent induced leukopenia does not preclude inclusion. Discussion of WBC \\\u003C 13,000\u002Fmm\\^3 due to treatment at the time of registration must be discussed with the Sponsor\u002FPrincipal Investigator.\n\n  * For a man or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of any study drug. Adequate contraception is defined as follows:\n* Complete true abstinence\n* Consistent and correct use of one of the following methods of birth control:\n\n  * Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient\n  * Implants of levonorgestrel\n  * Injectable progestogen\n  * Intrauterine device (IUD) with a documented failure rate of less than 1% per year\n  * Oral contraceptive pill (either combined or progesterone only)\n  * Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen\n\n    * WOCBP must have a negative serum or urine pregnancy test =\\\u003C 7 days prior to registration\n* NOTE: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\> 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), must be considered to be of child-bearing potential\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\nExclusion Criteria:\n\nPRE-REGISTRATION - EXCLUSION CRITERIA:\n\n* Previous exposure to an alternative (investigational) PLK1 inhibitor\n* Demonstration of transformation to acute leukemia on any prior bone marrow biopsy\n* Prior allogeneic hematopoietic stem cell transplantation with active grade 2-4 graft-versus-host disease (GVHD) or with moderate to severe chronic GVHD\n\n  * NOTE: The patient should not have received calcineurin inhibitors ≤28 days prior to pre-registration and should not be actively receiving immunosuppressive therapy for acute or chronic GVHD.\n  * NOTE: CMML or MDS\u002FMPN overlap neoplasms relapse after allogeneic stem cell transplant is allowed as long as they are \\>100 days after transplant and do not have the aforementioned GVHD criteria.\n* Active central nervous system disease\n* Concurrent active malignancy, except adequately treated nonmelanoma skin cancer. History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for \\> 2 years\n\n  * NOTE: Precursor states such as monoclonal gammopathy of undetermined significance (MGUS), monoclonal B-cell lymphocytosis (MBL), and indolent lymphoproliferative disorders must be discussed with the Sponsor\u002FPrincipal Investigator.\n* New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* Anticancer chemotherapy (exception: hydroxyurea) or biologic therapy administered within 2 weeks (and at least 4 elimination half-lives for clinical trial agents) prior to pre-registration. NOTE: Hydroxyurea is allowed for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the Sponsor\u002FPrincipal Investigator\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Major surgery =\\\u003C 6 weeks prior to pre-registration\n* Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (eg, intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)\n* Unable or unwilling to swallow study drug\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant nonhealing or healing wounds, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Known active infection with human immunodeficiency virus (HIV) with measurable viral titer, hepatitis B surface antigen positivity, or hepatitis C with measurable viral titer. NOTE: Patients with antibody to hepatitis B core antibody are eligible if they have no measurable viral titer. Patients who have had a hepatitis B virus (HBV) immunization are eligible\n* Patient is receiving any live vaccine (eg, varicella, pneumococcus) =\\\u003C 28 days prior to pre-registration. NOTE: messenger ribonucleic acid (mRNA)-based (eg, Pfizer or Moderna) or replication-deficient virus (eg, Oxford\u002FAstraZeneca) COVID19 vaccines are permitted\n* Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of \\>= 20 mg\u002Fday prednisone (or equivalent). Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids\n* Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* Strong CYP3A4 inhibitors\u002Finducers as identified per institutional guidelines\n* QT interval with Fridericia's correction (QTcF) \\> 470 milliseconds. In the case of potentially correctible causes of QT prolongation, (eg, medications, hypokalemia), the electrocardiogram (ECG) may be repeated once during screening and that result may be used to determine eligibility\n\nREGISTRATION - EXCLUSION CRITERIA:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Increased risk of Torsade des Pointes (TdP) defined as follows:\n\n  * A marked baseline prolongation of QT\u002FQTc interval (eg, repeated demonstration of a QTc interval \\> 480 msec \\[CTCAE Grade \\>= 2\\] using Fredericia's QT correction formula)\n  * A history of additional risk factors for TdP (eg. heart failure, family history of long QT syndrome)\n* Transformation to acute leukemia on registration bone marrow biopsy","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia and Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.",[26,27,28,29,30,31],"Recurrent Chronic Myelomonocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm, Not Otherwise Specified","Recurrent Atypical Chronic Myeloid Leukemia","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myelodysplastic\u002FMyeloproliferative Neoplasm","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":36},"2023-04-04",{"date":40,"type":20},"2027-12-01",{"name":42,"class":43},"Mayo Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100373289","phase-1-azacitidine-venetoclax-and-gilteritinib-in-treating-patients-with-recurrentrefractory-flt3-mutated-acute-myeloid-leukemia-chronic-myelomonocytic-leukemia-or-high-risk-myelodysplastic-syndromemyeloproliferative-neoplasm-100373289","NCT04140487","Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent\u002FRefractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm","A Phase I\u002FII Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults ≥ 18 years with newly diagnosed FLT3-mutated AML\n  * Phase II cohort B: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * For all cohorts, patients with either FLT3-internal tandem duplication (FLT3-ITD) or FLT3 D835 mutations will be eligible\n* Performance status ≤ 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior therapies:\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: No restriction on number of prior therapies\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\> 450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association criteria\n* Active central nervous system leukemia\n* Known human immunodeficiency virus (HIV) seropositive\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wort\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib",{"count":53,"type":20},97,[23,55],"PHASE2","This phase I\u002FII trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome\u002Fmyeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm.",[58,26,30,59,27,31],"Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","2026-04-13",{"date":62,"type":36},"2026-04-16",{"date":64,"type":36},"2019-12-17",{"date":66,"type":20},"2028-09-01",{"name":68,"class":43},"M.D. Anderson Cancer Center",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"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":77,"type":20},52,[23,55],"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.",[81,82,83,30,84,27,31,85],"Atypical Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Myeloproliferative Neoplasm","Refractory Myeloproliferative Neoplasm","2026-03-11",{"date":88,"type":36},"2026-03-13",{"date":90,"type":36},"2024-08-02",{"date":92,"type":20},"2028-10-31",{"name":94,"class":43},"Uma Borate",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":44},"100334179","phase-1-edetate-calcium-disodium-or-succimer-in-treating-patients-with-acute-myeloid-leukemia-or-myelodysplastic-syndrome-undergoing-chemotherapy-100334179","NCT03630991","Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy","Inclusion Criteria:\n\n* Patients ≥18 years of age, or their legally authorized representative (LAR), must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. For patients \\\u003C18 years of age, a parent or LAR must have the ability to understand the requirements of the study and must voluntarily sign the informed consent form. Any required verbal assent and\u002For signed assent of minor must be obtained for participants \\\u003C18 years.\n* Age ≥18 years at the time of signing the informed consent form.\n* Age ≥1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR)\n* Patients enrolling in the pediatric\u002Fadolescent\u002Fyoung adult exploratory cohort must be:\n\nAge ≥ 1 years and \\\u003C18 years with weight requirement ≥8 kg at the time of the signing of the informed consent form (e.g. by parent or LAR), Or age 18 years -39 years at the time of the signing of the informed consent form\n\n* Diagnosis of any of the following:\n* Newly diagnosed (or untreated) AML with intermediate-risk\u002Fpoor-risk cytogenetics, intermediate-risk\u002Fpoor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy)\n* Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia \\[CML\\])\n* Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS\u002Fmyeloid neoplasm\n* Newly diagnosed (or untreated) MDS\u002FMPN (regardless of cytogenetic\u002Fmolecular status)\n* Relapsed and\u002For refractory AML, MDS\u002Fmyeloid neoplasm , MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML)\n* Patients enrolling in the childhood\u002Fadolescent\u002Fyoung adult exploratory cohort may have any of the following diagnoses:\n* High-risk or relapsed\u002Frefractory childhood, adolescent, or young adult malignancies including but not limited to high-risk or relapsed\u002Frefractory ALL or other high-risk or relapsed refractory malignancies\n* This includes, but is not limited to, the following: High-risk ALL\u002FLL including T-ALL\u002FLL, Ph-like ALL\u002FLL, Ph+ B-ALL\u002FLL, B-ALL\u002FLL with CNS lymphoid leukemic involvement, testicular involvement, other extramedullary involvement by ALL\u002FLL; ALL\u002FLL with any of the NCI high-risk features: patients aged 10 years or older and those with a white blood cell count ≥50 × 109 per L), high-risk cytogenetics (MLL rearrangements, near haploidy \\[\\\u003C30 chromosomes\\], low hypodiploidy \\[30-39 chromosomes\\], t\\[17;19\\]\\[q23;p13\\], intrachromosomal amplification of chromosome 21), Burkitts'; Burkitt's-like, Double-Hitt; CNS involvement by any non-primary brain malignancy; Metastatic disease of any malignancy; 5-year survival prognosis of less than 50%, based on the treating physician's assessment\n* Patients on non-investigational regimens or on IND-exempt MD Anderson studies (for hematologic malignancies) of approved drugs are also eligible.\n* Patients on IND studies (for hematologic malignancies) utilizing FDA approved commercially available drugs are eligible.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an IND.\n* Newly diagnosed MDS or AML, as well as MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML), patients can enroll on this study after start of non-investigational induction therapy, but must be within first 3 cycles of therapy of front-line therapy. Patients with relapsed and\u002For refractory AML, MDS, MDS\u002FMPN, myeloid blast phase of MPN (including myeloid blast phase of CML) can enroll. Newly diagnosed patients enrolling in the exploratory cohort with high-risk malignancies can enroll after the start of non-investigational therapy but must be within first 3 cycles of front-line therapy.\n* Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Chronic Myeloid Leukemia (CML) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 3 or Lansky or Karnofsky ≥ 30 at study entry; patients who are unable to walk, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Total Bilirubin =\\\u003C 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's\n* AST (SGOT) and\u002For ALT (SGPT) =\\\u003C 2.0 x ULN\n* Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential\n* Extramedullary disease is allowed as long as it can be measured and followed for response.\n\nNote: Patients can be considered MDS by either WHO or FAB150 criteria Note: MDS risk status assessment is based on IPSS-R and\u002For IPSS-M. AML risk status assessment is based on ELN and World Health Organization classification\n\nExclusion Criteria:\n\n* Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk\n* Acute Promyelocytic leukemia (APL)","1 Year",{"count":104,"type":20},58,[23],"This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and\u002For improve response to chemotherapy.",[108,109,110,111,112,113,83,114,58,115,116,30,59,117,118,119,120,121],"Acute Myeloid Leukemia","Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Risk Myelodysplastic Syndrome","Myelodysplastic Syndrome","Myeloproliferative Neoplasm","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Recurrent Myelodysplastic Syndrome","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Myelodysplastic Syndrome","Secondary Acute Myeloid Leukemia","Secondary Myelodysplastic Syndrome","Very High Risk Myelodysplastic Syndrome","2026-02-26",{"date":124,"type":36},"2026-03-02",{"date":126,"type":36},"2018-10-11",{"date":128,"type":20},"2027-04-30",{"name":68,"class":43}]