Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06577441

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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