Actively Recruiting
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
93
Participants Needed
125
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.
CONDITIONS
Official Title
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be registered to the MYELOMATCH Master Screening and Reassessment Protocol before consenting
- Must have a detectable IDH2 mutation confirmed by central testing
- Newly diagnosed, untreated AML with 20% or more blasts in bone marrow or blood, excluding acute promyelocytic leukemia
- Must not be receiving or planning other investigational agents during protocol therapy
- No prior AML or related therapy except specified allowed treatments like hydroxyurea or a single dose of cytarabine
- White blood cell count less than 25 x 10^9/L before starting treatment; certain cytoreduction therapies allowed before protocol therapy
- Age 60 years or older, or age 18 or older and not eligible for cytarabine-based induction therapy
- Zubrod Performance Status of 0 to 3 within 14 days before registration
- Complete medical history and physical exam within 14 days before registration
- Total bilirubin less than or equal to 1.5 times upper normal limit (ULN), or up to 3 times ULN if history of Gilbert's syndrome
- AST and ALT less than or equal to 3 times ULN unless elevated due to disease involvement
- Adequate kidney function with creatinine clearance 30 mL/min or higher within 14 days before registration
- Corrected QT interval less than 480 msec; ECG recommended if clinically indicated
- Adequate cardiac function assessed by physician; NYHA Class 2 or better if cardiac history present
- HIV-positive participants must be on effective anti-retroviral therapy with undetectable viral load within 6 months
- History of hepatitis B must have undetectable viral load on suppressive therapy within 6 months
- History of hepatitis C must be treated and cured or have undetectable viral load if currently treated
- No prior or concurrent malignancy interfering with study safety or efficacy
- Not pregnant or nursing; effective contraception required for those of reproductive potential
- Able to swallow and retain oral medications without gastrointestinal disorders
- Agree to submit specimens for translational medicine and biobanking under MYELOMATCH
- Informed consent provided according to institutional and federal guidelines
You will not qualify if you...
- Acute promyelocytic leukemia with PML-RARA
- Receiving or planning to receive other investigational agents during protocol therapy
- Prior AML or related therapy not allowed except specified exceptions
- White blood cell count 25 x 10^9/L or higher before starting treatment
- QTc interval 480 msec or higher
- Cardiac function worse than NYHA Class 2
- Pregnant or nursing individuals
- Known or untreated malignancies that could interfere with study assessments
- Unable to swallow or retain oral medications
- Refusal or inability to provide informed consent or submit required specimens
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 125 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Actively Recruiting
5
Mills Health Center
San Mateo, California, United States, 94401
Actively Recruiting
6
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
7
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
8
Augusta University Medical Center
Augusta, Georgia, United States, 30912
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
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
18
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
19
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
20
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Actively Recruiting
21
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
22
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
Actively Recruiting
23
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
24
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
25
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Actively Recruiting
26
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
27
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
28
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
29
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
30
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
31
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
32
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
33
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
34
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
35
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
36
Our Lady of The Lake
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
37
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, United States, 04011
Actively Recruiting
38
Mid Coast Hospital
Brunswick, Maine, United States, 04011
Actively Recruiting
39
MaineHealth Maine Medical Center - Portland
Portland, Maine, United States, 04102
Actively Recruiting
40
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States, 04074
Actively Recruiting
41
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States, 04106
Actively Recruiting
42
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
43
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
44
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
45
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
46
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Actively Recruiting
47
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
48
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, United States, 49829
Actively Recruiting
49
Cancer Hematology Centers - Flint
Flint, Michigan, United States, 48503
Actively Recruiting
50
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Suspended
51
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Actively Recruiting
52
Allegiance Health
Jackson, Michigan, United States, 49201
Actively Recruiting
53
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
54
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
55
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
56
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
57
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
58
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
59
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
60
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
61
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
62
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
63
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
64
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
65
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
66
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
67
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
68
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
69
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
70
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
71
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
72
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
73
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
74
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
75
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
76
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
77
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
78
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
79
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
80
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
81
Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
82
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
83
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
84
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
85
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
86
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
87
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
88
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
89
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
90
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
91
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
92
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
93
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
94
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
95
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
96
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
97
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
98
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
99
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
100
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Actively Recruiting
101
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Actively Recruiting
102
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Actively Recruiting
103
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Actively Recruiting
104
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Actively Recruiting
105
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
106
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Actively Recruiting
107
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
108
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
109
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States, 98026
Actively Recruiting
110
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Actively Recruiting
111
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
112
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
113
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
114
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
115
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
116
William S Middleton VA Medical Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
117
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
118
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Actively Recruiting
119
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
120
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
121
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
122
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
123
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
124
Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico, 00927
Actively Recruiting
125
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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