New hope for older leukemia patients with gentler drug combo

NCT ID NCT04657081

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This study tests a new two-drug combination (ASTX727 and venetoclax) in adults with acute myeloid leukemia who are 75 or older, or have health issues that make standard strong chemotherapy too risky. The goal is to see if the drugs work well together and can control the leukemia. About 101 people will take part in this early-phase trial.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

101 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be 18 years of age or older. 2. Histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2016 criteria. 3. Projected life expectancy of at least 3 months. 4. Participants must be considered ineligible for intensive induction chemotherapy defined by the following: a) Age 75 years or older, or b) Age 18 to 74 years with at least one of the following comorbidities: i) Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina), ii) Severe pulmonary disorder (eg, diffusing lung capacity for carbon monoxide DLCO ≤65% or forced expiratory volume in 1 second \[FEV1\] ≤65%), iii) Creatinine clearance ≥30 mL/min to \<45 mL/min, iv) Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0 × upper limit of normal (ULN), v) Phase 1: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 (participants with ECOG ≥3 are not eligible); Phase 2, Parts A and B: ECOG Performance Status of 2 or 3 (participants with ECOG 4 are not eligible). 5. Phase 1: ECOG Performance Status of 0-2; Phase 2, Parts A and B: ECOG 0-3. 6. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group \[CTFG\]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. 7. Participants and their partners with reproductive potential must agree to use a highly effective contraceptive measure during the study and for 3 months after the last dose of study treatment, including refraining from sperm donation. Effective contraception includes methods such as oral contraceptives or double-barrier method (eg, use of a condom AND diaphragm, with spermicide). 8. Capable of giving legally effective informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol, and willing to participate in the study. Exclusion Criteria: 1. History of myeloproliferative neoplasm including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation. 2. The following karyotype abnormalities: t(8;21), inv(16) or t(15;17), or other acute promyelocytic leukemia variants that remain sensitive to all-trans retinoic acid (ATRA) therapy. 3. Known active central nervous system involvement from AML. 4. Known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). Human immunodeficiency virus testing will be performed at Screening, only if indicated per local guidelines or institutional standards. 5. Known active hepatitis B or C infection (detectable viral load). Hepatitis B or C testing will be performed at Screening, only if indicated per local guidelines or institutional standards. 6. Severe hepatic impairment defined as: bilirubin \>1.5×upper limit of normal (ULN) for participants ≥75 years or \>3×ULN for participants \<75 years; or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>3×ULN (unless considered to be due to leukemic organ involvement). 7. Severe renal impairment defined as: calculated creatinine clearance or glomerular filtration rate \<30 mL/min. 8. A malabsorption syndrome or other condition that precludes enteral route of administration. 9. Cardiovascular disability status of New York Heart Association Class \>2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain. 10. Chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications that in the opinion of the investigator would adversely affect his/her participating in this study. 11. Clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal). 12. History of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or adequately treated and controlled with other modalities); and any early stage malignancy for which no definitive therapy is required. 13. White blood cell (WBC) count \>25,000/μL (Hydroxyurea treatment is permitted to meet this criterion). 14. Treatment with the following: a) A hypomethylating agent (azacitidine or decitabine), or venetoclax including prior treatment for myelodysplastic syndrome (MDS), b) Chimeric Antigen Receptor (CAR)-T cell therapy, c) Investigational therapies for MDS or AML. 15. Participants who cannot discontinue concomitant prophylactic antifungal therapy with CYP3A inhibitor activity or other concomitant medications with moderate or strong CYP3A inhibitor activity ≥7 days or 5 half-lives, whichever is greater, prior to cycle 1 day 1 (C1D1). 16. Participants who cannot discontinue concomitant drugs that are strong CYP3A or P-gp inhibitors ≥7 days or 5 half-lives, whichever is greater, prior to C1D1. 17. Participants who cannot avoid concomitant drugs known as moderate or strong CYP3A inducers. 18. Current participation in another research study requiring interventions such as drug therapy or study procedures. 19. Known or suspected hypersensitivity to decitabine, cedazuridine, venetoclax, or any of their excipients. 20. Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol. 21. Participants who consume grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit ≤7 days prior to C1D1.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Baylor Scott & White Research Institute

Temple, Texas, 76508, United States
Boca Raton Clinical Research

Plantation, Florida, 33322, United States
Clinica Universidad de Navarra, Pamplona

Pamplona, Navarre, 31008, Spain
East Carolina University

Greenville, North Carolina, 27834, United States
Hackensack University of Medical Center

Hackensack, New Jersey, 07601, United States
Health Midwest Ventures Group, Inc.

Kansas City, Missouri, 64132, United States
Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain
Hospital Universitario Central de Asturias

Oviedo, Austrias, 33011, Spain
Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain
Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Institut Catala d'Oncologia-Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Jewish General Hospital

Montreal, H3T 1E2, Canada
MD Anderson Cancer Center

Houston, Texas, 77030, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Stanford University

Palo Alto, California, 94306, United States
The Ohio State University

Columbus, Ohio, 43210, United States
The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada
The Research Foundation of the State University of New York (SUNY)

Syracuse, New York, 13210, United States
The University of Chicago Medical Center

Chicago, Illinois, 60637, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain
University of Alberta

Edmonton, Alberta, T6G 2R3, Canada
University of Calgary - Health Sciences Centre

Calgary, Alberta, T2N 4N1, Canada
University of Massachusetts, Memorial Medical Center

Worcester, Massachusetts, 01655, United States
University of Rochester

Rochester, New York, 14627, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6307, United States
Weill Cornell Medical College

Ney York, New York, 10065, United States
Yale University

New Haven, Connecticut, 06510, United States

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