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New hope for AML patients: Three-Drug cocktail shows promise in phase 2 trial

NCT ID NCT04266795

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a drug called pevonedistat to the standard two-drug combination (venetoclax and azacitidine) helps adults recently diagnosed with acute myeloid leukemia (AML) who are too frail for intensive chemotherapy. About 164 participants received either the three-drug or two-drug regimen in 28-day cycles. The main goal was to see if the three-drug combo improved event-free survival (time without cancer worsening or death). The trial is now complete, and results will show if the extra drug offers a meaningful benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Oct 2020

Finished

Oct 2025

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: * Has morphologically confirmed diagnosis of AML (World Health Organization \[WHO\] criteria 2008). Participants may have newly diagnosed primary de novo AML or secondary AML (sAML), defined as AML after myelodysplastic syndromes (MDS) or myeloproliferative neoplasm (MPN), or therapy-related AML (t-AML) following cytotoxic therapy, and/or radiotherapy for a malignant or nonmalignant disease. * Is unfit for treatment with a standard arabinosylcytosine (Ara-C) and anthracycline induction regimen due to age or co-morbidities defined by 1 of the following: * ≥75 years of age. OR * ≥18 to \<75 years of age with at least one of the following: * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. * Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). * Severe pulmonary disorder (e.g., carbon monoxide lung diffusion capacity ≤65% or forced expiratory volume in 1 second ≤65%). * Creatinine clearance (CrCl) \<45 mL/min (but ≥30 mL/min as part of general eligibility criteria). * Hepatic disorder with total bilirubin \>1.5 times the upper limit of the normal range (ULN). * Has clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug): * Total bilirubin ≤1.5 times the ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll with direct bilirubin ≤3 times the ULN of the direct bilirubin. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times the ULN. * Creatinine clearance (CrCl) ≥30 mL/min (calculated by the Modification of Diet in Renal Disease \[MDRD\] Study equation). * Albumin \>2.7 g/dL. * White blood cell (WBC) count \<25 × 10\^9/L. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria before starting therapy. Exclusion Criteria: * Has history of MPN with BCR-ABL1 translocation or AML with BCR-ABL1 translocation. * Has genetic diagnosis of acute promyelocytic leukemia. * Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. * Has extramedullary AML without evidence of bone marrow involvement. * Had prior treatment with hypomethylating agents for AML (hypomethylating agent treatment for prior MDS is not exclusionary). * Has clinical evidence of or history of central nervous system involvement by AML. * Had diagnosed or treated for another malignancy (except for adequately treated carcinoma in situ of any organ or nonmelanoma skin cancer) within 1 year before randomization or previously diagnosed with another malignancy and have any evidence of residual disease that may compromise the administration of pevonedistat, venetoclax or azacitidine. Prior MDS is also allowed, but the participant cannot have received treatment for MDS within 14 days before first dose of any study drug. * Has a WBC count ≥25 × 10\^9/L * Has uncontrolled human immunodeficiency virus (HIV) infection. Note: Known HIV positive participants who meet the following criteria will be considered eligible: * Cluster difference 4 (CD4) count \>350 cells/mm\^3. * Undetectable viral load. * Maintained on modern therapeutic regimens utilizing non-cytochrome P (CYP)-interactive agents. * No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections. * Participant is known to be positive for hepatitis B or C infection, with the exception of those with an undetectable viral load within 3 months (hepatitis B or C testing is not required for eligibility assessment). * Has hepatic cirrhosis. * Has uncontrolled coagulopathy or bleeding disorder. * Has high blood pressure which cannot be controlled by standard treatments. * Has prolonged rate QTc interval ≥500 msec, calculated according to institutional guidelines. * Has left ventricular ejection fraction (LVEF) \<40%, based on echocardiogram or multi gated acquisition (MUGA) scan at screening (data to be available within last 3 months of screening). * As infection is a common feature of AML, participants with active infection are permitted to enroll provided that the infection is under control and no signs of systemic inflammatory response beyond low grade fever that makes participant clinically unstable in the opinion of the investigator. Participants with uncontrolled infection shall not be enrolled until infection is treated and brought under control.

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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 (AML)

Contacts and locations

Locations

  • ASST di Monza - Azienda Ospedaliera San Gerardo

    Monza, Lombardy, 20900, Italy

  • AdventHealth (Florida Hospital) - Transplant Institute

    Orlando, Florida, 32804, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Turin, Piedmont, 10126, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, 40138, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHRU Lille

    Lille, 59037, France

  • CHRU Nantes

    Nantes, 44093, France

  • CHRU de Poitiers La Miletrie

    Poitiers, 86021, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Nice

    Nice, 06202, France

  • Centre Hospitalier Le Mans

    Le Mans, Sarthe, 72000, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • EDOG - Institut Claudius Regaud - PPDS

    Toulouse, 31059, France

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100, Italy

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, Calabria, 89133, Italy

  • HCA Midwest Health - SCRI - PPDS

    Kansas City, Missouri, 64132, United States

  • Hopital Avicenne

    Bobigny, 93009, France

  • Hopital Saint Antoine

    Paris, 75012, France

  • Hopital Saint Louis

    Paris, 75475, France

  • Hopital de L'enfant Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6574, United States

  • Institut dHematologie de Basse Normandie

    Caen, 14033, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • Intermountain LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410, United States

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • MTZ Clinical Research Sp z o o

    Warsaw, Masovian Voivodeship, 02-106, Poland

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042, United States

  • Norton Cancer Institute - Suburban

    Louisville, Kentucky, 40207, United States

  • Ospedale Santa Maria Della Misericordia Di Perugia

    Perugia, Umbria, 06156, Italy

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081, Poland

  • Stony Brook Medicine

    Stony Brook, New York, 11794, United States

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • Tom Baker Cancer Centre

    Tom Baker Cancer Centre, Alberta, T2N 4N2, Canada

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514-4221, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, Łódź Voivodeship, 93-513, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.