Taking people in United StatesPhase 2

Testing enasidenib added to cedazuridine-decitabine for higher-risk IDH2-mutated myelodysplastic syndrome

Tests adding enasidenib to standard drugs in adults with higher-risk IDH2-mutated myelodysplastic syndrome.

Plain-language title generated from the registry record
Registry title: Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

Key facts

Where: Albany, Albuquerque, Anaconda, Ankeny, Ashland, Baton Rouge, Berkeley, Bethesda, Billings, Bloomington, Boiling Springs, Boise, Boston, Bozeman, Brainerd, Brighton, Buffalo, Canton, Carthage, Chelsea, Chicago, Clive, Coeur d'Alene, Columbus, Crown Point, Danville, Decatur, Deer River, DeKalb, Des Moines, Dixon, Duluth, Durham, Easley, Edina, Edmonds, Effingham, Eureka, Evanston, Fairway, Fargo, Farmington, Flint, Fruitland, Gainesville, Galesburg, Geneva, Glenview, Grayslake, Great Falls, Green Bay, Greenville, Greer, Hibbing, Highland Park, Hines, Iowa City, Irvine, Issaquah, Kalispell, Kansas City, Kewanee, Knoxville, La Crosse, Lake Forest, Lebanon, Livingston, Livonia, Long Branch, Louisville, Macomb, Madison, Mattoon, Maywood, Meridian, Miami, Milwaukee, Minneapolis, Missoula, Nampa, New Brunswick, New Lenox, O'Fallon, Oklahoma City, Orange, Orland Park, Ottawa, Pekin, Pella, Pembroke Pines, Peoria, Peru, Pittsburgh, Pontiac, Post Falls, Princeton, Richmond, Saint Louis Park, Saint Paul, Sainte Genevieve, Salt Lake City, San Mateo, Sandpoint, Sandstone, Seattle, Seneca, Springfield, St Louis, Stevens Point, Stony Brook, Sturgeon Bay, Sullivan, Toms River, Urbana, Virginia, Warrenville, Washington, Waukee, Weston, Westwood, Wilkes-Barre, and Ypsilanti, United StatesSee the 149 sites
Phase: Phase 2

Where in United States

Phoebe Putney Memorial HospitalAlbany, United StatesTaking people
University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
Duluth Clinic AshlandAshland, United StatesTaking people
LSU Health Baton Rouge-North ClinicBaton Rouge, United StatesTaking people
Our Lady of The LakeBaton Rouge, United StatesTaking people
Our Lady of the Lake Physician GroupBaton Rouge, United StatesTaking people
Alta Bates Summit Medical Center-Herrick CampusBerkeley, United StatesNo longer taking part
Walter Reed National Military Medical CenterBethesda, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
Prisma Health Cancer Institute - SpartanburgBoiling Springs, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
Tufts Medical CenterBoston, United StatesTaking people
Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
Essentia Health Saint Joseph's Medical CenterBrainerd, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
Illinois CancerCare-CantonCanton, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
Illinois CancerCare-CarthageCarthage, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
Northwestern UniversityChicago, United StatesTaking people
Swedish Covenant HospitalChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Essentia Health - Deer River ClinicDeer River, United StatesTaking people
Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
Iowa Methodist Medical CenterDes Moines, United StatesTaking people
Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
Illinois CancerCare-DixonDixon, United StatesTaking people
Essentia Health Cancer CenterDuluth, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
Prisma Health Cancer Institute - EasleyEasley, United StatesTaking people
Fairview Southdale HospitalEdina, United StatesTaking people
Minnesota Oncology - EdinaEdina, United StatesTaking people
Swedish Cancer Institute-EdmondsEdmonds, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
Illinois CancerCare-EurekaEureka, United StatesTaking people
NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesTaking people
University of Kansas Clinical Research CenterFairway, United StatesTaking people
Essentia Health Cancer Center-South University ClinicFargo, United StatesTaking people
Parkland Health Center - FarmingtonFarmington, United StatesTaking people
Cancer Hematology Centers - FlintFlint, United StatesTaking people
Genesys Hurley Cancer InstituteFlint, United StatesTaking people
Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesTaking people
Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesTaking people
Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
East Carolina UniversityGreenville, United StatesTaking people
Prisma Health Cancer Institute - ButternutGreenville, United StatesTaking people
Prisma Health Cancer Institute - EastsideGreenville, United StatesTaking people
Prisma Health Cancer Institute - FarisGreenville, United StatesTaking people
Prisma Health Cancer Institute - GreerGreer, United StatesTaking people
Essentia Health Hibbing ClinicHibbing, United StatesTaking people
NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesTaking people
Edward Hines Jr VA HospitalHines, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesTaking people
Swedish Cancer Institute-IssaquahIssaquah, United StatesTaking people
Logan Health Medical CenterKalispell, United StatesTaking people
University of Kansas Cancer CenterKansas City, United StatesTaking people
Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
University of Tennessee - KnoxvilleKnoxville, United StatesNo longer taking part
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
Cooperman Barnabas Medical CenterLivingston, United StatesTaking people
Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
Monmouth Medical CenterLong Branch, United StatesTaking people
The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
UofL Health Medical Center NortheastLouisville, United StatesTaking people
Illinois CancerCare-MacombMacomb, United StatesTaking people
William S Middleton VA Medical CenterMadison, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
Loyola University Medical CenterMaywood, United StatesTaking people
Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
Miami Cancer InstituteMiami, United StatesTaking people
Medical College of WisconsinMilwaukee, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Hennepin County Medical CenterMinneapolis, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
HSHS Saint Elizabeth's HospitalO'Fallon, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United StatesTaking people
Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
Illinois CancerCare-PekinPekin, United StatesTaking people
UI Healthcare Mission Cancer and Blood - PellaPella, United StatesTaking people
Memorial Hospital WestPembroke Pines, United StatesTaking people
Illinois CancerCare-PeoriaPeoria, United StatesTaking people
Illinois CancerCare-PeruPeru, United StatesTaking people
UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Regions HospitalSaint Paul, United StatesTaking people
United HospitalSaint Paul, United StatesTaking people
Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
Mills Health CenterSan Mateo, United StatesNo longer taking part
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
Essentia Health SandstoneSandstone, United StatesTaking people
Swedish Medical Center-First HillSeattle, United StatesTaking people
Prisma Health Cancer Institute - SenecaSeneca, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Missouri Baptist Medical CenterSt Louis, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
Stony Brook University Medical CenterStony Brook, United StatesTaking people
Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesTaking people
Missouri Baptist Sullivan HospitalSullivan, United StatesTaking people
Community Medical CenterToms River, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Essentia Health Virginia ClinicVirginia, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
Illinois CancerCare - WashingtonWashington, United StatesTaking people
UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people

Questions to ask the study team

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Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT06577441
Record updated: 4 November 2026
Original description: This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.Read full original descriptionShow less
A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study
This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.
Inclusion: GENERAL MYLEOMATCH REGISTRATION CRITERIA:; Patients must be registered to the Master Screening and Reassessment Protocol (MYELOMATCH) and assigned to this protocol by the MATCHBox Treatment Verification Team; Participants must not have received prior anti-cancer therapy for AML or MDS; Note: Hydroxyurea to control the white blood cell count (WBC) is allowed; Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility; Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine); REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor [g-CSF], thrombopoietin [TPO] agonist) or luspatercept is allowed; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with lenalidomide with a maximum limit of 1 month of exposure is allowed; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 3.0 x upper limit of normal (ULN); REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min; To be calculated using Cockroft Gault formula; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects; Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load; RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment; RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2; RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment; RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN); RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min; To be calculated using Cockroft Gault formula; RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.
ClinicalTrials.gov NCT06577441