[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556319":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":69,"centralContacts":73,"locations":79,"responsibleParty":99,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":64,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":64,"enrollmentInfo":116,"targetDuration":64,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":64,"overallStatus":81,"whyStopped":64,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Ohio State University Comprehensive Cancer Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I (Axatilimab)","EXPERIMENTAL","Patients receive axatilimab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At time of phase Ib completion, patients with clinical improvement may transition to phase II. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.",[13,14,15],"Biological: Axatilimab","Procedure: Biospecimen Collection","Procedure: Bone Marrow Aspiration and Biopsy",{"label":17,"type":10,"description":18,"interventionNames":19},"Phase II (Axatilimab and azacitidine)","Patients receive axatilimab IV over 30 minutes on days 1 and 15 and azacitidine IV over 10-40 minutes or SC on days 1-7 of each cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve PR or better may continue for up to 24 total cycles. Patients who achieve less than PR receive 2 additional cycles and, if PR or better is achieved, may complete up to 24 total cycles. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.",[13,20,14,15,21],"Drug: Azacitidine","Other: Survey Administration",[23,34,51,60,65],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Axatilimab","Given IV",[9,17],[29,30,31,32,33],"Anti-M-CSFR Monoclonal Antibody SNDX-6352","SNDX 6352","SNDX-6352","SNDX6352","UCB6352",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Azacitidine","Given IV or SC",[17],[40,41,42,43,44,45,46,47,48,49,50],"5 AZC","5-AC","5-Azacitidine","5-Azacytidine","5-AZC","Azacytidine","Azacytidine, 5-","Ladakamycin","Mylosar","U-18496","Vidaza",{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,17],[57,58,59],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Bone Marrow Aspiration and Biopsy","Undergo bone marrow biopsy and aspiration",[9,17],null,{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":64},"Survey Administration","Ancillary study",[17],[70],{"name":71,"affiliation":5,"role":72},"Uma M Borate, MD","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":64,"email":78},"The Ohio State University Comprehensive Cancer Center","CONTACT","800-293-5066","OSUCCCClinicaltrials@osumc.edu",[80],{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Columbus","Ohio","43210","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-82.99879,39.96118,{"lat":91,"lon":90},[94,98],{"name":95,"role":76,"phone":96,"phoneExt":64,"email":97},"Uma M. Borate","614-293-3316","Uma.Borate@osumc.edu",{"name":95,"role":72,"phone":64,"phoneExt":64,"email":64},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"SPONSOR_INVESTIGATOR","Uma Borate","Principal Investigator",[104],{"name":105,"class":106},"Incyte Corporation","INDUSTRY","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",false,"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","ALL","18 Years",{"count":117,"type":118},52,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE1","PHASE2","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.",[125,126,127,128,129,130,131,132],"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","2026-03-11",{"date":135,"type":136},"2026-03-13","ACTUAL",{"date":138,"type":136},"2024-08-02",{"date":140,"type":118},"2028-10-31",{"name":101,"class":6},1]