[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100315211":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":50,"centralContacts":54,"locations":61,"responsibleParty":100,"collaborators":102,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":59,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":59,"enrollmentInfo":118,"targetDuration":59,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":59,"overallStatus":88,"whyStopped":59,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (enasidenib, azacitidine)","EXPERIMENTAL","Patients who are HMA-naive receive enasidenib PO QD on days 1-28 and azacitidine IV over 30-60 minutes or SC on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.",[13,14,15],"Drug: Azacitidine","Drug: Enasidenib","Other: Quality-of-Life Assessment",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm II (enasidenib)","Patients relapsed and\u002For refractory to HMA therapy receive enasidenib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.",[14,15],[21,37,44],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azacitidine","Given IV or SC",[9],[27,28,29,30,31,32,33,34,35,36],"5 AZC","5-AC","5-Azacytidine","5-AZC","Azacytidine","Azacytidine, 5-","Ladakamycin","Mylosar","U-18496","Vidaza",{"type":22,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Enasidenib","Given PO",[9,17],[42,43],"AG-221","CC-90007",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Quality-of-Life Assessment","Ancillary studies",[9,17],[49],"Quality of Life Assessment",[51],{"name":52,"affiliation":5,"role":53},"Courtney DiNardo","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"Courtney DiNardo, MD","CONTACT","713-794-1141",null,"cdinardo@mdanderson.org",[62,76,86],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":59},"Johns Hopkins University\u002FSidney Kimmel Cancer Center","ACTIVE_NOT_RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-76.61219,39.29038,{"lat":74,"lon":73},{"facility":77,"status":64,"city":78,"state":79,"zip":80,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":85,"contacts":59},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":71,"coordinates":82},[83,84],-81.69541,41.4995,{"lat":84,"lon":83},{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":68,"countryCode":69,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030",{"type":71,"coordinates":93},[94,95],-95.36327,29.76328,{"lat":95,"lon":94},[98,99],{"name":52,"role":57,"phone":58,"phoneExt":59,"email":59},{"name":52,"role":53,"phone":59,"phoneExt":59,"email":59},{"type":101,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[103,106],{"name":104,"class":105},"National Cancer Institute (NCI)","NIH",{"name":107,"class":108},"Celgene","INDUSTRY","100315211","phase-2-azacitidine-and-enasidenib-in-treating-patients-with-idh2-mutant-myelodysplastic-syndrome-100315211",false,"NCT03383575","Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome","Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Signed, informed consent must be obtained prior to any study specific procedures\n* Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (acute myeloid leukemia \\[AML\\] with 20-30% blasts and multilineage dysplasia by French-American-British \\[FAB\\] criteria) by World Health Organization (WHO), and chronic myelomonocytic leukemia (CMML) are eligible\n* Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result\n* (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-directed therapy such as lenalidomide is allowed\n* (Arm A only): Subjects with high-risk MDS (i.e. International Prostate Symptom Score \\[IPSS\\] intermediate-2 or high-risk; or revised \\[R\\]-IPSS high or very-high risk). Patients with intermediate-1 risk by IPSS or intermediate risk by R-IPSS with high-risk molecular features including TP53, ASXL1, EZH2, and\u002For RUNX1 mutations are also eligible\n* (Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Serum bilirubin =\\\u003C 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) =\\\u003C 3 x the laboratory ULN\n* Serum creatinine =\\\u003C 2 x the ULN\n* Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements\n* Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =\\\u003C grade 1 prior to the first dose of study treatment\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (\\> 45 years old and without menses for \\> 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential\n\nExclusion Criteria:\n\n* Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study\n* Subject has received a prior targeted IDH2 inhibitor\n* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and\u002For completion of the necessary study procedures\n* Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C infection\n* Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy\n* Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement\n* Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months\n* Subjects with a corrected QT (QTc) \\> 480 ms (QTc \\> 510 msec for subjects with a bundle branch block at baseline\n* Nursing or pregnant women\n* Subjects with known hypersensitivity to study drugs or their excipients","ALL","12 Years",{"count":119,"type":120},63,"ESTIMATED","INTERVENTIONAL",[123],"PHASE2","This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[126,127,128,129,130,131,132],"Acute Myeloid Leukemia","Blasts 20-30 Percent of Bone Marrow Nucleated Cells","Chronic Myelomonocytic Leukemia","IDH2 Gene Mutation","Myelodysplastic Syndrome With Excess Blasts","Recurrent High Risk Myelodysplastic Syndrome","Refractory High Risk Myelodysplastic Syndrome","2026-02-13",{"date":135,"type":136},"2026-02-17","ACTUAL",{"date":138,"type":136},"2018-01-17",{"date":140,"type":120},"2027-02-28",{"name":5,"class":6},3]