A Phase 2 interventional study of Biospecimen Collection and Bone Marrow Aspiration in Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI). Recruiting at 64 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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Among 202 studies testing venetoclax in Leukemia, Myeloid, Acute — 116 open to participants now, 144 under way, 21 of them phase 3. venetoclax · Leukemia, Myeloid, Acute.
Among the 202 studies testing venetoclax in Leukemia, Myeloid, Acute, this one is the 49th largest by planned enrollment, is one of 28 that started in 2026, is one of 89 in phase 2, reaches primary completion later than 143 of the 143 other live ones, and was the 188th registered.
3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →116 of the 202 studies testing venetoclax in Leukemia, Myeloid, Acute are open now, in 12 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States, Puerto Rico
Ages 18–59
Virginia Commonwealth University · Sites in United States
Ages 18+
The First Affiliated Hospital of Soochow University · Sites in China
Ages 18+
Beijing 302 Hospital · Sites in China
Ages 18–70
Jacqueline Garcia, MD · Sites in United States
Ages 18–90
By country, each count listing its studies:
venetoclax: first FDA approval 2016 (VENCLEXTA), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
202 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 66 · Phase 2 127 · Phase 3 26 · Phase 4 5
First in 2010; this study’s year is marked. 28 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 126 is above the median of 40 across 3,006 interventional studies indexed under Leukemia, Myeloid, Acute.
Median enrollment 57 across the 202 interventional studies. Of the 46 that completed or were terminated, 15 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 202 have an industry lead sponsor. The 10 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
154 studies in Leukemia, Myeloid, Acute by National Cancer Institute (NCI): 21 open now, 41 under way, 1 of them phase 3. Of 107 finished, 39 (36%) have results posted.
Among the 154 studies in Leukemia, Myeloid, Acute by National Cancer Institute (NCI), this one is the 25th largest by planned enrollment of the 144 interventional ones that give a count, is one of 6 that started in 2026, is one of 51 in phase 2, reaches primary completion later than 36 of the 39 other live ones, and was the 153rd registered.
National Cancer Institute (NCI)’s Leukemia, Myeloid, Acute studies by the year they started, since 1996.
38 of the studies testing venetoclax in Leukemia, Myeloid, Acute that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07264010Phase 3Nanfang Hospital, Southern Medical UniversitySorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study | 2026-12-30 |
| NCT07486479Phase 3The First Affiliated Hospital of Soochow UniversityVenetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML | 2026-12-31 |
| NCT05183035Phase 3PedAL BCU, LLCVenetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | 2027-02 |
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT07514936Phase 3Chinese PLA General HospitalVenetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia | 2027-09-30 |
Add all 38 to your calendar (.ics) → With an account.
Among the 202 studies testing venetoclax in Leukemia, Myeloid, Acute, from their registry updates:
Among National Cancer Institute (NCI)’s 154 in Leukemia, Myeloid, Acute:
This tab as a report to print or save as PDF → With an account.
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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:
I. 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.
Inclusion Criteria:
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 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, 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
Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Drug: Decitabine and Cedazuridine · Drug: Venetoclax
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.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Drug: Decitabine and Cedazuridine · Drug: Venetoclax
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo bone marrow aspiration
Given PO
Also known as: ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi
Given PO
Also known as: ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
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.
Time frame: At 180 days
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.
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
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.
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
Will be estimated using the Kaplan-Meier method. Response per 2022 ELN risk will be tabulated and exact 95% confidence intervals will be calculated.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Mechanisms of resistance
Will be described by treatment arm.
Time frame: Up to 5 years
Drug sensitivity
Will be described by treatment arm.
Time frame: Up to 5 years
Tolerability
Will be characterized by the number of cycles completed by 6 months along with dose reductions and delays.
Time frame: At 180 days
Plan to share: 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.
Data sharing details ↗ · grants.nih.gov
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2034, 95 months after the start.
Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 95 months is above that.
Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
Start moved once since we started tracking on Sep 25, 2026: Apr 2027 → Sep 2026, on Sep 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Venetoclax
National Cancer Institute (NCI) →