Actively Recruiting
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)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
54
Participants Needed
140
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be registered to the Master Screening and Reassessment Protocol (MSRP) and assigned to this protocol by the MATCHBox Treatment Verification Team.
- Participants must not have received prior anti-cancer therapy for AML or MDS, except hydroxyurea to control white blood cell count and prior erythroid stimulating agents.
- Participants must not be currently receiving cytarabine-containing therapy other than up to 1 g/m2 for urgent cytoreduction.
- Prior use of hydroxyurea, all-trans retinoic acid, BCR-ABL tyrosine kinase inhibitors, erythropoiesis-stimulating agents, thrombopoietin receptor agonists, and lenalidomide is allowed.
- Patients must have a confirmed diagnosis of MDS with an IPSS-R score of 4 or higher.
- Patients must have a detectable pathogenic IDH2 mutation.
- No prior treatment with DNA methyltransferase inhibitors such as ASTX727, azacitidine, or decitabine.
- Prior treatment with growth factors, lenalidomide, or luspatercept allowed with a maximum of 1 month exposure.
- Patients with therapy-related MDS are allowed.
- Age must be 18 years or older.
- ECOG performance status must be 2 or less.
- Total bilirubin must be 1.5 times or less than the upper limit of normal (ULN), or up to 3.0 times ULN if due to Gilbert's syndrome.
- AST and ALT must be 3.0 times or less than ULN.
- Creatinine clearance must be 30 mL/min or higher.
- Women of childbearing potential must have a negative pregnancy test.
- Patients with prior or concurrent malignancy are eligible if it does not interfere with safety or efficacy assessment.
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible.
- Patients with chronic hepatitis B must have undetectable viral load on therapy.
- Patients with hepatitis C must be treated and cured or have undetectable viral load if on treatment.
- For re-registration after 6 cycles without complete response, the same performance status and lab criteria apply.
- Patients must not be pregnant or nursing at re-registration.
You will not qualify if you...
- Prior anti-cancer therapy for AML or MDS, except hydroxyurea for white blood cell control and prior erythroid stimulating agents.
- Current cytarabine-containing therapy above allowed urgent cytoreduction dose.
- Total bilirubin above 1.5 times ULN unless due to Gilbert's syndrome, in which case above 3.0 times ULN.
- AST or ALT above 3.0 times ULN.
- Creatinine clearance below 30 mL/min.
- Pregnant or nursing women.
- Patients with prior or concurrent malignancies that could interfere with safety or efficacy assessment.
- HIV infection without effective treatment or detectable viral load within 6 months.
- Active hepatitis B or C infection without undetectable viral load or cure.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 140 locations
1
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
Mills Health Center
San Mateo, California, United States, 94401
Actively Recruiting
5
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
6
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
7
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Actively Recruiting
8
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Actively Recruiting
9
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
10
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
11
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States, 83619
Actively Recruiting
12
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
13
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
14
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
15
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
16
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
17
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
18
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
19
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Actively Recruiting
20
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
21
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Actively Recruiting
22
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
23
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
24
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
25
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Actively Recruiting
26
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
27
Illinois CancerCare-Dixon
Dixon, Illinois, United States, 61021
Actively Recruiting
28
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
29
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Actively Recruiting
30
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
31
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
32
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Actively Recruiting
33
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
34
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
35
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
36
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
37
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Actively Recruiting
38
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Actively Recruiting
39
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
40
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Actively Recruiting
41
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
42
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
43
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
44
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
45
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States, 62269
Actively Recruiting
46
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
47
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
48
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
49
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
50
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
51
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
52
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Actively Recruiting
53
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
54
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
55
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Actively Recruiting
56
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
57
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
58
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
59
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
60
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
61
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
62
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
63
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
64
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
65
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
66
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
67
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa, United States, 50219
Actively Recruiting
68
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
69
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
70
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
71
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
72
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
73
Our Lady of The Lake
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
74
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Actively Recruiting
75
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
76
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
77
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
78
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
79
Cancer Hematology Centers - Flint
Flint, Michigan, United States, 48503
Actively Recruiting
80
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Suspended
81
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Actively Recruiting
82
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
83
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
84
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
85
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
86
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
87
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
88
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
89
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
90
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
91
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
92
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
93
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
94
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
95
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
96
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
97
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
98
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
99
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
100
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
101
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
102
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
103
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
104
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
105
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
106
Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
107
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
108
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
109
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
110
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
111
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
112
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
113
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
114
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
115
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
116
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
117
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
118
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Actively Recruiting
119
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Actively Recruiting
120
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Actively Recruiting
121
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Actively Recruiting
122
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Actively Recruiting
123
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
124
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Actively Recruiting
125
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
126
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
127
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
128
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States, 98026
Actively Recruiting
129
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Actively Recruiting
130
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
131
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
132
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
133
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
134
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
135
William S Middleton VA Medical Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
136
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
137
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
138
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
139
Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico, 00927
Actively Recruiting
140
San Juan City Hospital
San Juan, Puerto Rico, 00936
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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