Acute Myeloid LeukemiaPhase 2NCT07437950

Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Decitabine and Cedazuridine in people with Acute Myeloid Leukemia, run by National Cancer Institute (NCI) at 64 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Biospecimen Collection, Bone Marrow Aspiration and Decitabine and Cedazuridine
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 64 sitesin 2 countries
Study dates: 25 Sep 2026to 22 Sep 2034
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 60 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 been 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
Having recurrent AML-specific genetic abnormalities with ≥ 10% blasts in the bone marrow aspirate and/or peripheral blood
Participants with acute promyelocytic leukemia (APL) with PML-RARA are not eligible

Show all 32Show fewer

Participants must not have FLT3 mutations (ITD or TKD)
Participants must not have TP53 mutations
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, immunosuppressive therapy, intrathecal chemotherapy, a cumulative dose of up to 1 g/m^2 of cytarabine, 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/m2 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
Participant must be ≥ 60 years old at the time of registration
Participant must have been declared unfit for intensive therapy by the treating physician at the time of registration to MYELOMATCH
Participant must have Zubrod Performance Status of 0-3 within 28 days prior to registration
Participant must have a complete medical history and physical exam within 28 days prior to registration
Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN, unless considered elevated due to disease involvement (within 28 days prior to registration)
Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx
Participants must have adequate cardiac function. 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 3 or better
Participants with a known history of 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, if indicated
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 must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH.
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. Refer to MYELOMATCH for submission requirements and directions.
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. After performing the required tests on the specimens, the MDNet laboratories will send the residual material for biobanking and future research. 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 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

64 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

Sites recruiting now only

64 sites in 2 countries

United States62 sites, 62 recruiting

Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
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
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Eunice S. Wang
Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Rafael Madero Marroquin
Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Jayanshu Jain
Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Rafael Madero Marroquin
Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Fevzi Yalniz
Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Laura C. Michaelis
Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Rafael Madero Marroquin
Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
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
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Rafael Madero Marroquin
Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Chetan S. Jeurkar
Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
John L. Reagan
Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Eric J. Huselton
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
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramzi Abboud
Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Joseph J. Vadakara
Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
Recruiting

Other trials in United States

Puerto Rico2 sites, 2 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
Recruiting

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase II Trial of ASTX727 With Standard Duration Versus Shorter Duration of Venetoclax in Genomically Heterogenous AML Among Adults Aged 60 or Older and Less Fit for Intensive Therapy: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment trial compares ASTX727 with standard duration versus shorter duration of venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML). ASTX727 is a combination of decitabine and cedazuridine. 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. 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. 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. Shorter duration venetoclax may be as effective as standard duration venetoclax when given with ASTX727 for the treatment of newly diagnosed AML.

Read the detailed description

PRIMARY OBJECTIVES:

To compare whether the proportion of participants with a measurable residual disease (MRD) negative complete remission (CR) at 180 days (6 months) is not more than 12% worse between participants randomized to venetoclax for 14 days versus 28 days per cycle (non-inferiority assessment).

II. If 14 days of venetoclax is found to be non-inferior to 28 days, to test whether the proportion of participants with an MRD-negative CR at 180 days (6 months) after randomization is significantly higher in the 14 days per cycle compared to the 28-days per cycle (superiority assessment).

SECONDARY OBJECTIVES:

In each arm, to estimate the frequency and severity of toxicities. II. In each arm, to estimate CR rates, CR with incomplete count recovery (CRi) (CRi, with and without MRD) rates, event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) for each of the regimens.

III. In each arm, to use the disease characteristics from MATCHBox to describe mechanisms of resistance (and disease sensitivity) across the treatment arms.

IV. In each arm, to tabulate the number of cycles competed, percent of cycles with at least one dose reduction, and percent of cycles with at least one treatment delay at 180 days (6 months) after randomization.

BANKING OBJECTIVE:

To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive decitabine and cedazuridine (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 treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

ARM 2: Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Conditions: Acute Myeloid Leukemia
Being tested: Biospecimen Collection, Bone Marrow Aspiration, Decitabine and Cedazuridine, Venetoclax
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
Decitabine and CedazuridineDrug
Also called ASTX 727, ASTX-727, ASTX727, C-DEC
Given PO
VenetoclaxDrug
Also called ABT 199, ABT-0199, ABT-199, ABT199
Given PO

Study groups in NCT07437950
Study group	Role	What they receive
Arm 1 (ASTX727 with standard duration 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 treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Drug: Decitabine and Cedazuridine; Drug: Venetoclax
Arm 2 (ASTX727 with shorter duration venetoclax)	Experimental	Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Drug: Decitabine and Cedazuridine; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

Minimal residual disease (MRD) negative complete remission (CR)
Will compare the proportion of participants who achieve an MRD negative CR at 180 days between the two arms, including standard-of-care arm with 28 day duration of venetoclax in combination with ASTX727 versus experimental arm with 14 day duration of venetoclax in combination with ASTX727, using hierarchical testing to first assess that 14 days of venetoclax is not more than 12% worse than 28 days of venetoclax and if found to be non-inferior, test whether 14 days of venetoclax results in higher MRD negative CR at 180 days compared to the 28-day arm. Defined as from date of randomization the first of the following failure events: death from any cause, off protocol therapy without MRD negative CR, relapse from MRD negative CR, off protocol therapy without assessment of CR, off protocol therapy without assessment of MRD. Will be analyzed using intent-to-treat principles among eligible participants.
Measured: At 180 days

Secondary outcomes (8)

Event free survival
Will be estimated using the Kaplan-Meier method. Response per 2022 European Leukemia Network (ELN) risk will be tabulated and exact 95% confidence intervals will be calculated.
Measured: From randomization to first of: date off protocol therapy without complete remission (CR), CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh), relapse from CR, CRi, or CRh, or death from any cause, up to 5 years
Relapse free survival
Defined only for participants achieving CR, CRi, or CRh. Will be estimated using the Kaplan-Meier method. Response per 2022 ELN risk will be tabulated and exact 95% confidence intervals will be calculated.
Measured: From the date of achievement of a remission until the date of relapse or death from any cause, up to 5 years
Overall survival
Will be estimated using the Kaplan-Meier method. Response per 2022 ELN risk will be tabulated and exact 95% confidence intervals will be calculated.
Measured: From day of randomization on study until death from any cause, up to 5 years
Incidence of adverse events (AEs)
All AEs will be tabulated by Medical Dictionary for Regulatory Activities system organ class and preferred term. Grade 3-4 AE rates, serious AE rates, and rates of AEs leading to discontinuation between arms will be compared and risk will be reported with 95% confidence intervals (CI). Cumulative incidence of AEs of special interest (AESIs) will be calculated in each arm using the Kaplan-Meier method. Relative risk and risk difference of AESIs between arms at 180 days will be reported with 95% CI.
Measured: Up to 5 years
Rates of CR, CRi with and without MRD
Response per 2022 ELN risk will be tabulated and exact 95% confidence intervals will be calculated.
Measured: Up to 5 years
Mechanisms of resistance
Will be described by treatment arm.
Measured: Up to 5 years
Drug sensitivity
Will be described by treatment arm.
Measured: Up to 5 years
Tolerability
Will be characterized by the number of cycles completed by 6 months along with dose reductions and delays.
Measured: At 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202622 Sep 2034

First posted27 Feb 2026
Study start25 Sep 2026
Primary completion22 Sep 2034 (estimated)
Study completion22 Sep 2034 (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: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 126 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07437950
Sponsor's protocol ID: NCI-2026-01049
Other IDs: NCI-2026-01049, MM1OA-S04, MM1OA-S04, U10CA180888
Status last verified: Sep 2026
First submitted: 26 Feb 2026
Last updated: 6 Nov 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.

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
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Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase II Trial of ASTX727 With Standard Duration Versus Shorter Duration of Venetoclax in Genomically Heterogenous AML Among Adults Aged 60 or Older and Less Fit for Intensive Therapy: A MyeloMATCH Substudy
ClinicalTrials.gov ID: NCT07437950
Acronym / sponsor ID: NCI-2026-01049
Conditions: Acute Myeloid Leukemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 126 participants (estimated)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 25 Sep 2026 (actual)
Primary completion: 22 Sep 2034 (estimated)
Study completion: 22 Sep 2034 (estimated)
First posted: 27 Feb 2026 (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.

Detailed description

PRIMARY OBJECTIVES:

To compare whether the proportion of participants with a measurable residual disease (MRD) negative complete remission (CR) at 180 days (6 months) is not more than 12% worse between participants randomized to venetoclax for 14 days versus 28 days per cycle (non-inferiority assessment).

SECONDARY OBJECTIVES:

In each arm, to estimate the frequency and severity of toxicities. II. In each arm, to estimate CR rates, CR with incomplete count recovery (CRi) (CRi, with and without MRD) rates, event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) for each of the regimens.

III. In each arm, to use the disease characteristics from MATCHBox to describe mechanisms of resistance (and disease sensitivity) across the treatment arms.

BANKING OBJECTIVE:

To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1 (ASTX727 with standard duration venetoclax)	Active comparator	Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, 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 treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.
Arm 2 (ASTX727 with shorter duration venetoclax)	Experimental	Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Drug: Decitabine and Cedazuridine, Drug: VenetoclaxPatients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or treatment discontinuation. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (32 listed)

Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have been 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
Participants with acute promyelocytic leukemia (APL) with PML-RARA are not eligible
Participants must not have FLT3 mutations (ITD or TKD)
Participants must not have TP53 mutations

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 with standard duration venetoclax), Arm 2 (ASTX727 with shorter duration venetoclax)
Bone Marrow AspirationUndergo bone marrow aspiration	Procedure or surgery	Arm 1 (ASTX727 with standard duration venetoclax), Arm 2 (ASTX727 with shorter duration venetoclax)
Decitabine and CedazuridineAlso: ASTX 727, ASTX-727, ASTX727, C-DECGiven PO	Drug	Arm 1 (ASTX727 with standard duration venetoclax), Arm 2 (ASTX727 with shorter duration venetoclax)
VenetoclaxAlso: ABT 199, ABT-0199, ABT-199, ABT199Given PO	Drug	Arm 1 (ASTX727 with standard duration venetoclax), Arm 2 (ASTX727 with shorter duration venetoclax)

Primary outcome

Minimal residual disease (MRD) negative complete remission (CR)
Time frame: At 180 days
Will compare the proportion of participants who achieve an MRD negative CR at 180 days between the two arms, including standard-of-care arm with 28 day duration of venetoclax in combination with ASTX727 versus experimental arm with 14 day duration of venetoclax in combination with ASTX727, using hierarchical testing to first assess that 14 days of venetoclax is not more than 12% worse than 28 days of venetoclax and if found to be non-inferior, test whether 14 days of venetoclax results in higher MRD negative CR at 180 days compared to the 28-day arm. Defined as from date of randomization the first of the following failure events: death from any cause, off protocol therapy without MRD negative CR, relapse from MRD negative CR, off protocol therapy without assessment of CR, off protocol therapy without assessment of MRD. Will be analyzed using intent-to-treat principles among eligible participants.

8 secondary outcomes

Event free survival
Time frame: From randomization to first of: date off protocol therapy without complete remission (CR), CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh), relapse from CR, CRi, or CRh, or death from any cause, up to 5 years
Relapse free survival
Time frame: From the date of achievement of a remission until the date of relapse or death from any cause, up to 5 years
Overall survival
Time frame: From day of randomization on study until death from any cause, up to 5 years
Incidence of adverse events (AEs)
Time frame: Up to 5 years
Rates of CR, CRi with and without MRD
Time frame: Up to 5 years
Mechanisms of resistance
Time frame: Up to 5 years
Drug sensitivity
Time frame: Up to 5 years
Tolerability
Time frame: At 180 days

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 6 Nov 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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Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

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.

Kootenai Health - Coeur d'Alene

Coeur d'Alene, United States

406-969-6060

mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Post Falls

Post Falls, United States

406-969-6060

mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, United States

406-969-6060

mccinfo@mtcancer.org

Uma M Borate principal investigator

SWOG Cancer Research Network

64 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 32 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 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 (MRD) negative complete remission (CR) (time frame: At 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07437950.

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 6 Nov 2026.