Acute Myeloid LeukemiaPhase 2NCT06672146
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 138 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 138 sitesin 2 countries
- Study dates
- 16 May 2025to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
- 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
- Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy
- 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.
- 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.
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- Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy
- 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
- Participants must have a complete medical history and physical exam within 14 days prior to registration
- 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)
- 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)
- Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration
- Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
- 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
- Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted
- 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
- 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
- Participants must be offered the opportunity to participate in specimen banking
- 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
- 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. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Who cannot join
None listed.
Trial locations and contacts
138 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
138 sites in 2 countries
United States136 sites, 126 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Charles Foucar
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Vamsi Kota
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Harry G. Sequeira Gross
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Harry G. Sequeira Gross
- Recruiting
Our Lady of The Lake
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659
Harry G. Sequeira Gross
- Active, not recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Andreas K. Klein
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Pamela Egan
- Recruiting
Mid Coast Hospital
Brunswick, Maine, 04011
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Pamela Egan
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Eunice S. Wang
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Brittany K. Ragon
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Himachandana Atluri
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Noah Birch
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Olatoyosi M. Odenike
- Active, not recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Olatoyosi M. Odenike
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Joseph J. Vadakara
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Himachandana Atluri
- Active, not recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Harry P. Erba
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
David L. Grinblatt
- Recruiting
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Kenneth Byrd
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Himachandana Atluri
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
David L. Grinblatt
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Himachandana Atluri
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Himachandana Atluri
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Darla K. Liles
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
David L. Grinblatt
- Recruiting
Edward Hines Jr VA Hospital
Hines, Illinois, 60141
Site Public Contact, 708-202-8387
Jorgena Kosti-Schwartz
- Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Site Public Contact, 954-265-1847, OHR@mhs.net
Stanislav Ivanov
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Active, not recruiting
Allegiance Health
Jackson, Michigan, 49201
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Kenneth Byrd
- Suspended
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Himachandana Atluri
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Patrick W. Mellors
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Ankur Varma
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Site Public Contact, 973-322-5200
Neil D. Palmisiano
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Neil D. Palmisiano
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Mohamed M. Hegazi
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu
Mohamed M. Hegazi
- Recruiting
William S Middleton VA Medical Center
Madison, Wisconsin, 53705
Site Public Contact, 608-256-1901 ext. 17007
Christopher D. Fletcher
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Stephanie B. Tsai
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Site Public Contact, 786-596-2000
Firas El Chaer
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Guru Subramanian Guru Murthy
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Neil D. Palmisiano
- Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Olatoyosi M. Odenike
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Xin Wang
- Active, not recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Manu Pandey
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Himachandana Atluri
- Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Olatoyosi M. Odenike
- Recruiting
Memorial Hospital West
Pembroke Pines, Florida, 33028
Site Public Contact, 954-265-4325
Stanislav Ivanov
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Lindsay Wilde
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Annie P. Im
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Pamela Egan
- Suspended
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
John L. Reagan
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Keri R. Maher
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Eric J. Huselton
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Paul J. Shami
- Recruiting
UCSF Medical Center-Parnassus
San Francisco, California, 94143
Site Public Contact, 877-827-3222
Timothy Ferng
- Active, not recruiting
Mills Health Center
San Mateo, California, 94401
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Pamela Egan
- Recruiting
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Pamela Egan
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Suhu Liu
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Site Public Contact, 315-464-5476
Teresa C. Gentile
- Recruiting
Community Medical Center
Toms River, New Jersey, 08755
Site Public Contact, 732-557-8294, Lennette.Gonzales@rwjbh.org
Neil D. Palmisiano
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Sharad Khurana
- Recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Sharad Khurana
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
Xin Wang
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Himachandana Atluri
- Active, not recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Adedayo A. Onitilo
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Kenneth Byrd
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Joseph J. Vadakara
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Matthew J. Wieduwilt
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety of decitabine and cedazuridine (ASTX727) + venetoclax + enasidenib (Arm 2) before initiating randomization.
II. To compare the rate of measurable residual disease (MRD) negative complete remission with or without partial hematologic recovery (complete remission [CR] or complete remission with partial hematologic recovery [CRh]) based on multiparameter flow cytometry (MFC) after two cycles of treatment in older adults (or unfit adults age 18 or older) with IDH2 mutated acute myeloid leukemia (AML) who receive ASTX727, venetoclax, and enasidenib versus ASTX727 and venetoclax alone.
III. If the rate of measurable residual disease (MRD) negative CR+CRh is significantly higher on the ASTX727, venetoclax, and enasidenib arm compared to the ASTX727 and venetoclax arm, to hierarchically evaluate whether the measurable residual disease (MRD) negative CR rate is different between the randomized arms.
SECONDARY OBJECTIVES:
- To estimate the rate of composite remission (CR + complete remission with incomplete count recovery [CRi] + complete remission with partial hematologic recovery [CRh]), relapse-free survival (RFS), event-free survival (EFS), duration of response (DOR), and overall survival (OS) of participants by treatment arm.
II. To estimate IDH2 mutated variant allele frequency, flow cytometry MRD, and molecular MRD after two cycles of therapy in participants' bone marrow aspirates and blood by treatment arm.
III. To estimate remission rates (CR with and without MRD [MFC and molecular MRD], CRh and CRi), and to estimate the rates of hematologic improvement by treatment arm.
IV. To estimate the frequency and severity of adverse events by treatment arm. V. To evaluate the association between MFC and molecular MRD after two cycles of protocol treatment with the outcomes RFS and OS (landmarked by date of MRD measurement) by treatment arm.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive ASTX727 orally (PO) once daily (QD) on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months until 5 years after registration or death.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, Enasidenib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Decitabine and CedazuridineDrug
Also called ASTX 727, ASTX-727, ASTX727, C-DEC
Given PO
EnasidenibDrug
Also called AG 221, AG-221, AG221, CC-90007 Free Base
Given PO
VenetoclaxDrug
Also called ABT 199, ABT-0199, ABT-199, ABT199
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (ASTX727 + venetoclax) | Active comparator | Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Decitabine and Cedazuridine; Drug: Venetoclax |
| Arm 2 (ASTX727 + venetoclax + enasidenib) | Experimental | Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Decitabine and Cedazuridine; Drug: Enasidenib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease negative (MRDneg) complete remission (CR) rate
A randomized design will be used to compare binary endpoints in two arms with a single interim futility analysis. For the final analysis, a 2-sample proportion z-test will be used to compare the MRDneg-CR+complete remission with partial hematologic recovery (CRh) rates between arms with a two-sided alpha of 20%.
Measured: Baseline to 5 years
Secondary outcomes (4)
Relapse-free survival (RFS)
Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Landmark Kaplan-Meier plots will be used describe marker associations with overall survival (OS) and RFS. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Measured: Baseline to 5 years
Event-free survival
Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Molecular and flow MRD rates in the peripheral blood will be tabulated and summarized by arm. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Measured: Baseline to 5 years
Duration of response
Response and toxicity rates will be tabulated. Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Measured: Baseline to 5 years
OS
Survival endpoints will be estimated using the Kaplan-Meier method and compared between arms using the log-rank test. Landmark survival endpoints after 2- and 4-cycles of therapy will be estimated using the Kaplan-Meier method. Time-dependent Cox regression models with response as a time-dependent covariate will be fit. Molecular and flow MRD rates in the peripheral blood will be tabulated and summarized by arm. Landmark Kaplan-Meier plots will be used describe marker associations with OS and RFS. Landmark and time-dependent Cox regression models will be fit with marker values as covariates. If endpoints subject to competing risks are analyzed, non-parametric cumulative incidence rates will be calculated, and associations will be evaluated using cause-specific hazard models
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start16 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric J Huselton, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672146
- Sponsor's protocol ID
- NCI-2024-08951
- Other IDs
- NCI-2024-08951, MM1OA-S03, MM1OA-S03, U10CA180888
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06672146
- Acronym / sponsor ID
- NCI-2024-08951
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety of decitabine and cedazuridine (ASTX727) + venetoclax + enasidenib (Arm 2) before initiating randomization.
II. To compare the rate of measurable residual disease (MRD) negative complete remission with or without partial hematologic recovery (complete remission [CR] or complete remission with partial hematologic recovery [CRh]) based on multiparameter flow cytometry (MFC) after two cycles of treatment in older adults (or unfit adults age 18 or older) with IDH2 mutated acute myeloid leukemia (AML) who receive ASTX727, venetoclax, and enasidenib versus ASTX727 and venetoclax alone.
III. If the rate of measurable residual disease (MRD) negative CR+CRh is significantly higher on the ASTX727, venetoclax, and enasidenib arm compared to the ASTX727 and venetoclax arm, to hierarchically evaluate whether the measurable residual disease (MRD) negative CR rate is different between the randomized arms.
SECONDARY OBJECTIVES:
- To estimate the rate of composite remission (CR + complete remission with incomplete count recovery [CRi] + complete remission with partial hematologic recovery [CRh]), relapse-free survival (RFS), event-free survival (EFS), duration of response (DOR), and overall survival (OS) of participants by treatment arm.
II. To estimate IDH2 mutated variant allele frequency, flow cytometry MRD, and molecular MRD after two cycles of therapy in participants' bone marrow aspirates and blood by treatment arm.
III. To estimate remission rates (CR with and without MRD [MFC and molecular MRD], CRh and CRi), and to estimate the rates of hematologic improvement by treatment arm.
IV. To estimate the frequency and severity of adverse events by treatment arm. V. To evaluate the association between MFC and molecular MRD after two cycles of protocol treatment with the outcomes RFS and OS (landmarked by date of MRD measurement) by treatment arm.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive ASTX727 orally (PO) once daily (QD) on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.
After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months until 5 years after registration or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (ASTX727 + venetoclax) | Active comparator | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Drug: Decitabine and Cedazuridine, Drug: VenetoclaxPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial. |
| Arm 2 (ASTX727 + venetoclax + enasidenib) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Drug: Decitabine and Cedazuridine, Drug: Enasidenib, Drug: VenetoclaxPatients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
- 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
- Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy
- 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.
- Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm 1 (ASTX727 + venetoclax), Arm 2 (ASTX727 + venetoclax + enasidenib) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Arm 1 (ASTX727 + venetoclax), Arm 2 (ASTX727 + venetoclax + enasidenib) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow biopsy | Procedure or surgery | Arm 1 (ASTX727 + venetoclax), Arm 2 (ASTX727 + venetoclax + enasidenib) |
| Decitabine and CedazuridineAlso: ASTX 727, ASTX-727, ASTX727, C-DECGiven PO | Drug | Arm 1 (ASTX727 + venetoclax), Arm 2 (ASTX727 + venetoclax + enasidenib) |
| EnasidenibAlso: AG 221, AG-221, AG221, CC-90007 Free BaseGiven PO | Drug | Arm 2 (ASTX727 + venetoclax + enasidenib) |
| VenetoclaxAlso: ABT 199, ABT-0199, ABT-199, ABT199Given PO | Drug | Arm 1 (ASTX727 + venetoclax), Arm 2 (ASTX727 + venetoclax + enasidenib) |
Primary outcome
Minimal residual disease negative (MRDneg) complete remission (CR) rate
Time frame: Baseline to 5 years
A randomized design will be used to compare binary endpoints in two arms with a single interim futility analysis. For the final analysis, a 2-sample proportion z-test will be used to compare the MRDneg-CR+complete remission with partial hematologic recovery (CRh) rates between arms with a two-sided alpha of 20%.
4 secondary outcomes
Relapse-free survival (RFS)
Time frame: Baseline to 5 years
Event-free survival
Time frame: Baseline to 5 years
Duration of response
Time frame: Baseline to 5 years
OS
Time frame: Baseline to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric J Huselton principal investigator
SWOG Cancer Research Network
138 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 138 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 138 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease negative (MRDneg) complete remission (CR) rate (time frame: Baseline to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.