{ "data": { "asOf": "2026-10-30T22:27:00.341Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06672146", "title": "Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)", "scientificTitle": "A Randomized Phase II Trial of ASTX727 and Venetoclax Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Acute Myeloid Leukemia" ], "interventions": [ { "name": "Biospecimen Collection", "type": "PROCEDURE", "description": "Undergo blood sample collection" }, { "name": "Bone Marrow Aspiration", "type": "PROCEDURE", "description": "Undergo bone marrow aspiration" }, { "name": "Bone Marrow Biopsy", "type": "PROCEDURE", "description": "Undergo bone marrow biopsy" }, { "name": "Decitabine and Cedazuridine", "type": "DRUG", "description": "Given PO" }, { "name": "Enasidenib", "type": "DRUG", "description": "Given PO" }, { "name": "Venetoclax", "type": "DRUG", "description": "Given PO" } ], "sponsor": { "name": "National Cancer Institute (NCI)", "type": "NIH" }, "locations": [ { "city": "Tucson", "country": "United States", "facility": "Banner University Medical Center - Tucson" }, { "city": "Tucson", "country": "United States", "facility": "University of Arizona Cancer Center-North Campus" }, { "city": "Little Rock", "country": "United States", "facility": "University of Arkansas for Medical Sciences" }, { "city": "Berkeley", "country": "United States", "facility": "Alta Bates Summit Medical Center-Herrick Campus" }, { "city": "San Francisco", "country": "United States", "facility": "UCSF Medical Center-Parnassus" }, { "city": "San Mateo", "country": "United States", "facility": "Mills Health Center" }, { "city": "Hollywood", "country": "United States", "facility": "Memorial Regional Hospital/Joe DiMaggio Children's Hospital" }, { "city": "Miami", "country": "United States", "facility": "Miami Cancer Institute" }, { "city": "Pembroke Pines", "country": "United States", "facility": "Memorial Hospital West" }, { "city": "Augusta", "country": "United States", "facility": "Augusta University Medical Center" }, { "city": "Boise", "country": "United States", "facility": "Saint Luke's Cancer Institute - Boise" }, { "city": "Coeur d'Alene", "country": "United States", "facility": "Kootenai Health - Coeur d'Alene" }, { "city": "Fruitland", "country": "United States", "facility": "Saint Luke's Cancer Institute - Fruitland" }, { "city": "Meridian", "country": "United States", "facility": "Saint Luke's Cancer Institute - Meridian" }, { "city": "Nampa", "country": "United States", "facility": "Saint Alphonsus Cancer Care Center-Nampa" }, { "city": "Nampa", "country": "United States", "facility": "Saint Luke's Cancer Institute - Nampa" }, { "city": "Post Falls", "country": "United States", "facility": "Kootenai Clinic Cancer Services - Post Falls" }, { "city": "Sandpoint", "country": "United States", "facility": "Kootenai Clinic Cancer Services - Sandpoint" }, { "city": "Chicago", "country": "United States", "facility": "Northwestern University" }, { "city": "Chicago", "country": "United States", "facility": "University of Illinois" }, { "city": "Chicago", "country": "United States", "facility": "University of Chicago Comprehensive Cancer Center" }, { "city": "DeKalb", "country": "United States", "facility": "Northwestern Medicine Cancer Center Kishwaukee" }, { "city": "Evanston", "country": "United States", "facility": "NorthShore University HealthSystem-Evanston Hospital" }, { "city": "Geneva", "country": "United States", "facility": "Northwestern Medicine Cancer Center Delnor" }, { "city": "Glenview", "country": "United States", "facility": "NorthShore University HealthSystem-Glenbrook Hospital" }, { "city": "Glenview", "country": "United States", "facility": "Northwestern Medicine Glenview Outpatient Center" }, { "city": "Grayslake", "country": "United States", "facility": "Northwestern Medicine Grayslake Outpatient Center" }, { "city": "Highland Park", "country": "United States", "facility": "NorthShore University HealthSystem-Highland Park Hospital" }, { "city": "Hines", "country": "United States", "facility": "Edward Hines Jr VA Hospital" }, { "city": "Lake Forest", "country": "United States", "facility": "Northwestern Medicine Lake Forest Hospital" }, { "city": "Maywood", "country": "United States", "facility": "Loyola University Medical Center" }, { "city": "New Lenox", "country": "United States", "facility": "UC Comprehensive Cancer Center at Silver Cross" }, { "city": "Orland Park", "country": "United States", "facility": "Northwestern Medicine Orland Park" }, { "city": "Orland Park", "country": "United States", "facility": "University of Chicago Medicine-Orland Park" }, { "city": "Warrenville", "country": "United States", "facility": "Northwestern Medicine Cancer Center Warrenville" }, { "city": "Crown Point", "country": "United States", "facility": "UChicago Medicine Northwest Indiana" }, { "city": "Fairway", "country": "United States", "facility": "University of Kansas Clinical Research Center" }, { "city": "Kansas City", "country": "United States", "facility": "University of Kansas Cancer Center" }, { "city": "Westwood", "country": "United States", "facility": "University of Kansas Hospital-Westwood Cancer Center" }, { "city": "Louisville", "country": "United States", "facility": "The James Graham Brown Cancer Center at University of Louisville" }, { "city": "Louisville", "country": "United States", "facility": "UofL Health Medical Center Northeast" }, { "city": "Baton Rouge", "country": "United States", "facility": "LSU Health Baton Rouge-North Clinic" }, { "city": "Baton Rouge", "country": "United States", "facility": "Our Lady of the Lake Physician Group" }, { "city": "Baton Rouge", "country": "United States", "facility": "Our Lady of The Lake" }, { "city": "Brunswick", "country": "United States", "facility": "MaineHealth Cancer Care and IV Therapy - 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Flint" }, { "city": "Flint", "country": "United States", "facility": "Genesee Hematology Oncology PC" }, { "city": "Flint", "country": "United States", "facility": "Genesys Hurley Cancer Institute" }, { "city": "Jackson", "country": "United States", "facility": "Allegiance Health" }, { "city": "Livonia", "country": "United States", "facility": "Trinity Health Saint Mary Mercy Livonia Hospital" }, { "city": "Novi", "country": "United States", "facility": "Henry Ford Medical Center-Columbus" }, { "city": "Pontiac", "country": "United States", "facility": "Trinity Health Saint Joseph Mercy Oakland Hospital" }, { "city": "West Bloomfield", "country": "United States", "facility": "Henry Ford West Bloomfield Hospital" }, { "city": "Ypsilanti", "country": "United States", "facility": "Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus" }, { "city": "Coon Rapids", "country": "United States", "facility": "Mercy Hospital" }, { "city": "Deer River", "country": "United States", "facility": "Essentia Health - Deer River Clinic" }, { "city": "Duluth", "country": "United States", "facility": "Essentia Health Cancer Center" }, { "city": "Edina", "country": "United States", "facility": "Fairview Southdale Hospital" }, { "city": "Edina", "country": "United States", "facility": "Minnesota Oncology - Edina" }, { "city": "Hibbing", "country": "United States", "facility": "Essentia Health Hibbing Clinic" }, { "city": "Minneapolis", "country": "United States", "facility": "Abbott-Northwestern Hospital" }, { "city": "Saint Louis Park", "country": "United States", "facility": "Park Nicollet Clinic - Saint Louis Park" }, { "city": "Saint Paul", "country": "United States", "facility": "Regions Hospital" }, { "city": "Saint Paul", "country": "United States", "facility": "United Hospital" }, { "city": "Sandstone", "country": "United States", "facility": "Essentia Health Sandstone" }, { "city": "Virginia", "country": "United States", "facility": "Essentia Health Virginia Clinic" }, { "city": "Anaconda", "country": "United States", "facility": "Community Hospital of Anaconda" }, { "city": "Billings", "country": "United States", "facility": "Billings Clinic Cancer Center" }, { "city": "Bozeman", "country": "United States", "facility": "Bozeman Health Deaconess Hospital" }, { "city": "Great Falls", "country": "United States", "facility": "Benefis Sletten Cancer Institute" }, { "city": "Kalispell", "country": "United States", "facility": "Logan Health Medical Center" }, { "city": "Missoula", "country": "United States", "facility": "Community Medical Center" }, { "city": "Lebanon", "country": "United States", "facility": "Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center" }, { "city": "Basking Ridge", "country": "United States", "facility": "Memorial Sloan Kettering Basking Ridge" }, { "city": "Livingston", "country": "United States", "facility": "Cooperman Barnabas Medical Center" }, { "city": "Long Branch", "country": "United States", "facility": "Monmouth Medical Center" }, { "city": "Middletown", "country": "United States", "facility": "Memorial Sloan Kettering Monmouth" }, { "city": "Montvale", "country": "United States", "facility": "Memorial Sloan Kettering Bergen" }, { "city": "New Brunswick", "country": "United States", "facility": "Rutgers Cancer Institute of New Jersey" }, { "city": "Toms River", "country": "United States", "facility": "Community Medical Center" }, { "city": "Albuquerque", "country": "United States", "facility": "University of New Mexico Cancer Center" }, { "city": "Buffalo", "country": "United States", "facility": "Roswell Park Cancer Institute" }, { "city": "Commack", "country": "United States", "facility": "Memorial Sloan Kettering Commack" }, { "city": "Harrison", "country": "United States", "facility": "Memorial Sloan Kettering Westchester" }, { "city": "New York", "country": "United States", "facility": "Memorial Sloan Kettering Cancer Center" }, { "city": "Rochester", "country": "United States", "facility": "University of Rochester" }, { "city": "Stony Brook", "country": "United States", "facility": "Stony Brook University Medical Center" }, { "city": "Syracuse", "country": "United States", "facility": "State University of New York Upstate Medical University" }, { "city": "Uniondale", "country": "United States", "facility": "Memorial Sloan Kettering Nassau" }, { "city": "Charlotte", "country": "United States", "facility": "Carolinas Medical Center/Levine Cancer Institute" }, { "city": "Durham", "country": "United States", "facility": "Duke University Medical Center" }, { "city": "Greenville", "country": "United States", "facility": "East Carolina University" }, { "city": "Winston-Salem", "country": "United States", "facility": "Wake Forest University Health Sciences" }, { "city": "Oklahoma City", "country": "United States", "facility": "University of Oklahoma Health Sciences Center" }, { "city": "Portland", "country": "United States", "facility": "Oregon Health and Science University" }, { "city": "Danville", "country": "United States", "facility": "Geisinger Medical Center" }, { "city": "Philadelphia", "country": "United States", "facility": "Thomas Jefferson University Hospital" }, { "city": "Pittsburgh", "country": "United States", "facility": "UPMC Hillman Cancer Center" }, { "city": "Wilkes-Barre", "country": "United States", "facility": "Geisinger Wyoming Valley/Henry Cancer Center" }, { "city": "Providence", "country": "United States", "facility": "Rhode Island Hospital" }, { "city": "Boiling Springs", "country": "United States", "facility": "Prisma Health Cancer Institute - Spartanburg" }, { "city": "Easley", "country": "United States", "facility": "Prisma Health Cancer Institute - Easley" }, { "city": "Greenville", "country": "United States", "facility": "Prisma Health Cancer Institute - Butternut" }, { "city": "Greenville", "country": "United States", "facility": "Prisma Health Cancer Institute - Faris" }, { "city": "Greenville", "country": "United States", "facility": "Prisma Health Cancer Institute - Eastside" }, { "city": "Greer", "country": "United States", "facility": "Prisma Health Cancer Institute - Greer" }, { "city": "Seneca", "country": "United States", "facility": "Prisma Health Cancer Institute - Seneca" }, { "city": "Knoxville", "country": "United States", "facility": "University of Tennessee - Knoxville" }, { "city": "Salt Lake City", "country": "United States", "facility": "Huntsman Cancer Institute/University of Utah" }, { "city": "Richmond", "country": "United States", "facility": "VCU Massey Comprehensive Cancer Center" }, { "city": "Edmonds", "country": "United States", "facility": "Swedish Cancer Institute-Edmonds" }, { "city": "Issaquah", "country": "United States", "facility": "Swedish Cancer Institute-Issaquah" }, { "city": "Seattle", "country": "United States", "facility": "Swedish Medical Center-First Hill" }, { "city": "Ashland", "country": "United States", "facility": "Duluth Clinic Ashland" }, { "city": "Green Bay", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center Green Bay" }, { "city": "Green Bay", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center at Saint Mary's" }, { "city": "La Crosse", "country": "United States", "facility": "Gundersen Lutheran Medical Center" }, { "city": "Madison", "country": "United States", "facility": "William S Middleton VA Medical Center" }, { "city": "Milwaukee", "country": "United States", "facility": "Medical College of Wisconsin" }, { "city": "Oconto Falls", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center at Oconto Falls" }, { "city": "Sheboygan", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center at Sheboygan" }, { "city": "Sheboygan", "country": "United States", "facility": "Sheboygan Physicians Group" }, { "city": "Stevens Point", "country": "United States", "facility": "Marshfield Medical Center-River Region at Stevens Point" }, { "city": "Sturgeon Bay", "country": "United States", "facility": "Saint Vincent Hospital Cancer Center at Sturgeon Bay" }, { "city": "Weston", "country": "United States", "facility": "Marshfield Medical Center - Weston" }, { "city": "San Juan", "country": "Puerto Rico", "facility": "Centro Comprensivo de Cancer de UPR" }, { "city": "San Juan", "country": "Puerto Rico", "facility": "San Juan City Hospital" } ], "outcomes": { "other": [], "primary": [ "Minimal residual disease negative (MRDneg) complete remission (CR) rate" ], "secondary": [ "Relapse-free survival (RFS)", "Event-free survival", "Duration of response", "OS" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study\n\n * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH\n* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and/or peripheral blood, or with an AML defining genetic abnormality as described by the World Health Organization (WHO) classification of AML, excluding acute promyelocytic leukemia (APL) with PML-RARA\n* Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy\n* Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, luspatercept, immunosuppressive therapy, intrathecal chemotherapy, cytarabine (up to 1 g/m\\^2 for the purpose of cytoreduction for hyperleukocytosis/trial eligibility), and/or leukapheresis, with a maximum limit of 1 month of exposure.\n\n * Note: White blood cell (WBC) must be \\< 25 x 10\\^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m\\^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy.\n* Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy\n* Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\\&P) exam completed within 14 days prior to registration\n* Participants must have a complete medical history and physical exam within 14 days prior to registration\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration)\n* Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration\n* Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).\n\n * NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03\n* Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted\n\n * Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH\n * In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants\n* Participants must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. 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