[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07392242":3,"trial-entities:NCT07392242":157,"trial-summary:NCT07392242":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":15,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":72,"locations":75,"central_contacts":144,"overall_officials":150,"references":153,"see_also_links":154},"NCT07392242","25-224","A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia","A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia","RECRUITING","2028-01","2026-07","2026-07-17","2026-01-27","Memorial Sloan Kettering Cancer Center","OTHER",null,"The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.",[18],"Acute Myeloid Leukemia",[20,21,22,5],"Ivosidenib","Azacitidine","Venetoclax","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},45,"ESTIMATED",[31,36,39],{"type":32,"name":20,"description":33,"armGroupLabels":34},"DRUG","Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)",[35],"Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone",{"type":32,"name":21,"description":37,"armGroupLabels":38},"Azacitidine (IV or SC per institutional preference, days 1 through 7)",[35],{"type":32,"name":22,"description":40,"armGroupLabels":41},"Venetoclax (days 1 through 14)",[35],[43],{"measure":44,"description":45,"timeFrame":46},"Event free survival","Event-free survival is defined as the time between date of treatment start to treatment failure (failure to achieve complete remission or \\\u003C5% bone marrow blasts), confirmed relapse or death.","12 months",[],"ALL","60 Years",false,{"inclusion":52,"exclusion":60,"raw_text":71},[53,54,55,56,57,58,59],"Participant must be at least 60 years of age at the time of signing the informed consent form (ICF).","Participant is willing and able to adhere to the study visit schedule and other protocol requirements.","Participant has newly diagnosed AML as per World Health Organization 2022 or European leukemia Network 2022 guidelines.","Participant has IDH1-R132 mutation present prior to initiating Ivo\u002FAza\u002FVen confirmed by CLIA approved local testing via next-generation sequencing (NGS) and\u002For polymerase chain reaction (PCR). Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator.","Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3","Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).","Participant has adequate organ function defined as:",[61,62,63,64,65,66,67,68,69,70],"Participant with acute promyelocytic leukemia","Participants who have previously received ivosidenib or venetoclax","Participant receiving any other investigational anti-cancer agents. Cytoreductive therapy such as hydroxyurea is permitted.","Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation","Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).","Participants who are planned for allogeneic stem cell transplantation based on the assessment of the treating clinician.","Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke","Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.","Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Participants with a QTcF over 450 ms due","Male or female participants not willing to comply with contraceptive requirements","Inclusion Criteria:\n\n* Participant must be at least 60 years of age at the time of signing the informed consent form (ICF).\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participant has newly diagnosed AML as per World Health Organization 2022 or European leukemia Network 2022 guidelines.\n* Participant has IDH1-R132 mutation present prior to initiating Ivo\u002FAza\u002FVen confirmed by CLIA approved local testing via next-generation sequencing (NGS) and\u002For polymerase chain reaction (PCR). Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator.\n\n  1. At MSK, this testing will utilize the MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State. Other sites may use local CLIA-certified laboratories and validated clinical assays as per standard of care.\n  2. The patient's chart will be utilized for screening purposes\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3\n* Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).\n* Participant has adequate organ function defined as:\n\n  1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  2. Serum total bilirubin \\\u003C 3.0 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  3. Serum creatinine \\\u003C 2 x ULN or creatinine clearance 30 mL\u002Fmin based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.\n\nExclusion Criteria:\n\n* Participant with acute promyelocytic leukemia\n* Participants who have previously received ivosidenib or venetoclax\n* Participant receiving any other investigational anti-cancer agents. Cytoreductive therapy such as hydroxyurea is permitted.\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participants who are planned for allogeneic stem cell transplantation based on the assessment of the treating clinician.\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). As per exclusion criteria 5, patients receiving appropriate treatment would only be excluded if there is no improvement.\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Participants with a QTcF over 450 ms due\n* Male or female participants not willing to comply with contraceptive requirements",[73,74],"ADULT","OLDER_ADULT",[76,90,99,108,118,127,135],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":87},"Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[83],{"name":84,"role":85,"phone":86},"Kuo-Kai Chin, MD","CONTACT","646-608-4415",{"lat":88,"lon":89},40.70621,-74.54932,{"facility":91,"status":8,"city":92,"state":79,"zip":93,"country":81,"contacts":94,"geoPoint":96},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[95],{"name":84,"role":85,"phone":86},{"lat":97,"lon":98},40.39428,-74.11709,{"facility":100,"status":8,"city":101,"state":79,"zip":102,"country":81,"contacts":103,"geoPoint":105},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[104],{"name":84,"role":85,"phone":86},{"lat":106,"lon":107},41.04676,-74.02292,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":81,"contacts":113,"geoPoint":115},"Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)","Commack","New York","11725",[114],{"name":84,"role":85,"phone":86},{"lat":116,"lon":117},40.84288,-73.29289,{"facility":119,"status":8,"city":120,"state":111,"zip":121,"country":81,"contacts":122,"geoPoint":124},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[123],{"name":84,"role":85,"phone":86},{"lat":125,"lon":126},40.96899,-73.71263,{"facility":128,"status":8,"city":111,"state":111,"zip":129,"country":81,"contacts":130,"geoPoint":132},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[131],{"name":84,"role":85,"phone":86},{"lat":133,"lon":134},40.71427,-74.00597,{"facility":136,"status":8,"city":137,"state":111,"zip":138,"country":81,"contacts":139,"geoPoint":141},"Memorial Sloan Kettering Nassau (Limited Protocol Activites)","Rockville Centre","11553",[140],{"name":84,"role":85,"phone":86},{"lat":142,"lon":143},40.65871,-73.64124,[145,147],{"name":84,"role":85,"phone":86,"email":146},"chin3@mskcc.org",{"name":148,"role":85,"phone":149},"Eytan Stein, MD","646-608-3749",[151],{"name":84,"affiliation":13,"role":152},"PRINCIPAL_INVESTIGATOR",[],[155],{"label":13,"url":156},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":158,"biomarkers":159},[18],[160],"IDH1 Gene",{"nct_id":4,"found":162,"summary":163,"prompt_version":173},true,{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This study is an interventional study with a planned enrollment of 45 participants. The phase of the study is not specified.","completed","Study of Ivosidenib, Azacitidine, and Venetoclax for AML with IDH1 Mutation","This study is looking at a new treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH1 mutation. Researchers are testing a combination of three drugs: ivosidenib, azacitidine, and venetoclax. After this initial treatment, participants will continue with ivosidenib alone as maintenance therapy (additional treatment to help prevent cancer from returning). The main goal is to see how long people live without their disease getting worse (event-free survival) at 12 months. To join, you must be at least 60 years old and have newly diagnosed AML with an IDH1 mutation. The study plans to enroll 45 participants, but its current status is unclear.","The primary endpoint, event-free survival, is measured at 12 months.",108,"Ivosidenib is given on days 15-28 for the first cycle, then days 1-28 for subsequent cycles. Azacitidine is given on days 1-7, and Venetoclax is given on days 1-14.","Not stated in the trial record.",[20,21,22],"v2"]