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New pill combo extends life for leukemia patients too frail for strong chemo

NCT ID NCT03069352

Disease control Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the drug venetoclax to a low-dose chemotherapy (LDAC) helps people with acute myeloid leukemia (AML) live longer. It included 211 adults aged 75+ or 18–74 with health issues that prevent them from receiving strong chemotherapy. The main goal was to see if the combination improves overall survival compared to LDAC alone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

211 people

The number who actually took part.

Started

May 2017

Finished

Aug 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: 1. Participant must have histological confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be: * ≥ 75 years of age OR * ≥ 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy: * Eastern Cooperative Oncology Group (ECOG) performance status of 2 - 3 * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina * Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65% * Creatinine clearance ≥ 30 mL/min to \< 45 ml/min * Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN) * Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment 2. Participant must have an ECOG performance status: * of 0 to 2 for subjects ≥ 75 years of age OR * of 0 to 3 for subjects between 18 to 74 years of age 3. Participant must have a projected life expectancy of at least 12 weeks. 4. Participant must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection. 5. Participant must have adequate liver function as demonstrated by: * aspartate aminotransferase (AST) ≤ 3.0 × ULN\* * alanine aminotransferase (ALT) ≤ 3.0 × ULN\* * bilirubin ≤ 1.5 × ULN\* * Subjects who are \< 75 years of age may have bilirubin of ≤ 3.0 × ULN (\*Unless considered to be due to leukemic organ involvement.) 6. Female participants must be either postmenopausal defined as: * Age \> 55 years with no menses for 12 or more months without an alternative medical cause. * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level \> 40 IU/L. OR * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). OR * A woman of childbearing potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug. 7. Male participants who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug. 8. Females of childbearing potential must have negative results for pregnancy test performed: * At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and * Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been \> 7 days since obtaining the serum pregnancy test results. * Subjects with borderline pregnancy tests at Screening must have a serum pregnancy test ≥ 3 days later to document continued lack of a positive result. 9. Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Exclusion Criteria: 1. Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for myelodysplastic syndrome is allowed except for use of cytarabine. 2. Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation. 3. Participants that have acute promyelocytic leukemia (APL). 4. Participant has known central nervous system (CNS) involvement with AML. 5. Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Screening, if required per local guidelines or institutional standards. 6. Participant is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded. 7. Participant has received strong or moderate cytochrome P450 3A4 (CYP3A) inducers 7 days prior to the initiation of study treatment. * Chinese subjects are excluded from receiving strong and/or moderate CYP3A inhibitors 7 days prior to the initiation of study treatment through the end of intensive pharmacokinetic (PK) collection (24 hours post dose on Cycle 1 Day 10). 8. Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the initiation of study treatment. 9. Participant has cardiovascular disability status of New York Heart Association Class \> 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain. Class 3 is defined as cardiac disease which subjects are comfortable at rest but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4 is defined as cardiac disease which subjects have an inability to carry on any physical activity without discomfort, symptoms of heart failure at rest, and if any physical activity is undertaken then discomfort increases. 10. Participant has 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 including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study. 11. Participant has a malabsorption syndrome or other condition that precludes enteral route of administration. 12. Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). 13. Participant has a history of other malignancies prior to study entry, with the exception of: * Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. 14. Participant has a white blood cell count \> 25 × 10\^9/L. (Note: hydroxyurea administration or leukapheresis is permitted to meet this criterion). 15. Previous treatment with venetoclax and/or current participation in any other research study with investigational products.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia 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

  • Akita University Hospital /ID# 160602

    Akita, 100041, Japan

  • Alfred Hospital /ID# 160125

    Melbourne, Victoria, 3004, Australia

  • Almazov North-West Federal Med /ID# 162170

    Saint Petersburg, 197341, Russia

  • Bacs-Kiskun Megyei Korhaz /ID# 160973

    Kecskemét, 6000, Hungary

  • Beaumont Hospital /ID# 162733

    Dublin, D09 XR63, Ireland

  • Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509

    Tianjin, Tianjin Municipality, 300020, China

  • Box Hill Hospital /ID# 162920

    Melbourne, Victoria, 3128, Australia

  • CHU Bordeaux /ID# 159704

    Pessac, 33600, France

  • CHU De Nancy /ID# 159700

    Vandœuvre-lès-Nancy, 54511, France

  • CISSS de la Monteregie /ID# 159782

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Calvary Mater Newcastle /ID# 160123

    Waratah, New South Wales, 2298, Australia

  • Casa de Saúde Santa Marcelina /ID# 163413

    São Paulo, 08270-070, Brazil

  • Cath Univ Seoul St Mary's Hosp /ID# 158724

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • Cemic /Id# 159676

    Buenos Aires, 1431, Argentina

  • Centre Hospitalier Le Mans /ID# 159702

    Le Mans, Sarthe, 72037, France

  • Centre Hospitalier Lyon Sud /ID# 159705

    Pierre-Bénite, Rhone, 69495, France

  • Centre Hospitalier de la Cote /ID# 159697

    Bayonne, 64100, France

  • Centro de Invest Clin Chapulte /ID# 162625

    Morelia, Michoacán, 58260, Mexico

  • Centro de Pesquisas Oncologicas /ID# 163567

    Florianópolis, Santa Catarina, 88034-000, Brazil

  • Chungnam National University Hospital /ID# 158726

    Junggu, Daejeon Gwang Yeogsi, 35015, South Korea

  • City Clinical Hospital Botkina /ID# 164086

    Moscow, 125284, Russia

  • Cliniques Universitaires Saint Luc /ID# 159567

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Debreceni Egyetem Klinikai Koz /ID# 158178

    Debrecen, 4032, Hungary

  • Dokkyo Medical University Hosp /ID# 159650

    Shimotsuga, 321-0293, Japan

  • Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127

    Budapest IX, Budapest, 1097, Hungary

  • Fakult Nem Kralovske Vinohrady /ID# 159248

    Prague, 100 34, Czechia

  • Fakultni Nemocnice Brno /ID# 159247

    Brno, 625 00, Czechia

  • Fujian Medical Univ Union Hosp /ID# 167321

    Fuzhou, Fujian, 350001, China

  • Gen Univ Hosp Alexandroupolis /ID# 157868

    Alexandroupoli, 68100, Greece

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869

    Athens, 10676, Greece

  • General Hospital of Athens Laiko /ID# 157870

    Athens, Attica, 115 27, Greece

  • General Hospital of Thessaloniki George Papanikolaou /ID# 157867

    Thessaloniki, 57010, Greece

  • Gundersen Health System /ID# 164272

    La Crosse, Wisconsin, 54601, United States

  • Gunmaken Saiseikai Maebashi Hospital /ID# 160597

    Maebashi, Gunma, 371-0821, Japan

  • H. Lee Moffit Cancer Center /ID# 164273

    Tampa, Florida, 33612, United States

  • Haukeland University Hospital /ID# 165630

    Bergen, Hordaland, 5021, Norway

  • Heartlands Hospital /ID# 163534

    Birmingham, B9 5SS, United Kingdom

  • Henan Cancer Hospital /ID# 167327

    Zhengzhou, Henan, 450008, China

  • Hopital Sacre Coeur Montreal /ID# 160982

    Montreal, Quebec, H4J 1C5, Canada

  • Hosp. Univ. Dr. Jose E. Gonz /ID# 159268

    Monterrey, Nuevo León, 64320, Mexico

  • Hospital Infanta Leonor /ID# 161180

    Madrid, 28031, Spain

  • Hospital Maisonneuve-Rosemont /ID# 159780

    Montreal, Quebec, H1T 2M4, Canada

  • Hospital Universitario y Politecnico La Fe /ID# 161181

    Valencia, Valenciana, 46026, Spain

  • Hospital de Cancer de Barretos /ID# 163568

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital do Cancer Mae de Deus /ID# 163416

    Porto Alegre, 90470-150, Brazil

  • Instituto Nacional de Cancerol /ID# 159269

    Mexico City, Mexico City, 14080, Mexico

  • Jiangsu Province People's Hospital /ID# 167511

    Nanjing, Jiangsu, 210029, China

  • Juntendo University Hospital /ID# 159781

    Tokyo, 113-8431, Japan

  • Kaohsiung Medical University /ID# 161693

    Kaohsiung City, 80708, Taiwan

  • Kaposi Mor Oktato Korhaz /ID# 158175

    Kaposvár, 7400, Hungary

  • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991

    Kemerovo, Kemerovo Oblast, 650066, Russia

  • Kinki University -Osakasayama Campus /ID# 160777

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kyoto Prefect Univ Med /ID# 160101

    Kyoto, Kyoto, 602-8566, Japan

  • Kyushu University Hospital /ID# 159688

    Fukuoka, Fukuoka, 812-8582, Japan

  • Middlemore Clinical Trials /ID# 160131

    Auckland, 2025, New Zealand

  • NHO Nagoya Medical Center /ID# 159768

    Nagoya, 460-0001, Japan

  • NTT Medical Center Tokyo /ID# 160678

    Shinagawa-ku, Tokyo, 141-8625, Japan

  • Nagasaki University Hospital /ID# 160233

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nanfang Hospital of Southern Medical University /ID# 170147

    Guangzhou, Guangdong, 510515, China

  • National Hospital Organization Mito Medical Center /ID# 162988

    Higashi Ibaraki-gun, Ibaraki, 3113193, Japan

  • National Taiwan Univ Hosp /ID# 162781

    Taipei City, Taipei, 10002, Taiwan

  • Netcare Pretoria East Hospital /ID# 157373

    Pretoria, Gauteng, 0001, South Africa

  • Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

  • North Shore Hospital /ID# 160132

    Auckland, 0622, New Zealand

  • Northwick Park Hospital /ID# 162727

    Harrow, HA1 3UJ, United Kingdom

  • Norton Cancer Institute /ID# 158998

    Louisville, Kentucky, 40202-3700, United States

  • Osaka City University Hospital /ID# 159722

    Osaka, Osaka, 545-0051, Japan

  • Pecsi Tudomanyegyetem /ID# 163161

    Pécs, Pecs, 7624, Hungary

  • Petz Aladar Megyei Oktato Korh /ID# 161739

    Győr, 9023, Hungary

  • Pusan National University Hosp /ID# 158725

    Busan, Busan Gwang Yeogsi, 602-739, South Korea

  • Qilu Hospital of Shandong Univ /ID# 167507

    Jinan, 250014, China

  • Ruijin Hospital, Shanghai Jiaotong /ID# 167325

    Shanghai, Shanghai Municipality, 200025, China

  • Saint Petersburg State Institu /ID# 162171

    Saint Petersburg, 198205, Russia

  • Saitama Med Univ Int Med Ctr /ID# 161308

    Hidaka, 350-1241, Japan

  • Samara State Medical Universit /ID# 164173

    Samara, 443099, Russia

  • Sanatorio Allende /ID# 159675

    Córdoba, 5000, Argentina

  • Schwarzwald-Baar-Klinikum /ID# 159571

    Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

  • Semmelweis Egyetem I. Belklini /ID# 158180

    Budapest, 1083, Hungary

  • Seoul National University Hospital /ID# 162253

    Seoul, 03080, South Korea

  • St. James's Hospital /ID# 162730

    Dublin, Dublin, D08 E9P6, Ireland

  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126

    Ryazan, Ryazan Oblast, 390039, Russia

  • Swedish Medical Center /ID# 161280

    Seattle, Washington, 98104, United States

  • Sykehuset Ostfold Kalnes /ID# 165632

    Grålum, 1714, Norway

  • The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324

    Hangzhou, Zhejiang, 310003, China

  • The First Hosp of Jilin Univ /ID# 167512

    Changchun, Jilin, 130021, China

  • Tohoku University Hospital /ID# 161151

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Jikei Daisan Hospital /ID# 159769

    Komae-shi, Tokyo, 201-8601, Japan

  • Tokyo Metropolitan Komagome Hospital /ID# 160759

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • Tri-Service General Hospital /ID# 161683

    Taipei City, Taipei, 11490, Taiwan

  • Tshwane District Hospital /ID# 157361

    Pretoria, Gauteng, 0001, South Africa

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515

    Wuhan, 430022, China

  • Univ Hosp Ostrava-Poruba /ID# 159246

    Ostrava, 708 52, Czechia

  • Univ TX, MD Anderson /ID# 159678

    Houston, Texas, 77030, United States

  • Univ of Pittsburgh Med Ctr /ID# 158997

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Hamburg /ID# 161760

    Hamburg, 20246, Germany

  • Universitair Ziekenhuis Antwerpen /ID# 159566

    Edegem, Antwerpen, 2650, Belgium

  • University Gen Hosp of Patra /ID# 157871

    Pátrai, 26504, Greece

  • University Hospital Galway /ID# 162734

    Galway, H91 YR71, Ireland

  • University Hospital Limerick /ID# 162735

    Limerick, V94F858, Ireland

  • University Hospital of Wales /ID# 162726

    Cardiff, CF14 4EN, United Kingdom

  • University of Alberta Hospital /ID# 159646

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Fukui Hospital /ID# 159770

    Yoshida-gun, Fukui, 910-1193, Japan

  • VA Caribbean Healthcare System /ID# 158999

    San Juan, 00921-3201, Puerto Rico

  • Vivantes Klinikum Am Urban /ID# 159569

    Berlin, 10967, Germany

  • West China Hospital /ID# 167514

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital /ID# 160121

    Westmead, New South Wales, 2145, Australia

  • Yamagata University Hospital /ID# 161223

    Yamagata, Yamagata, 990-9585, Japan

  • Yaroslavl Regional Clinic Hosp /ID# 162172

    Yaroslavl, 150062, Russia

  • saratov state medical /ID# 163130

    Saratov, 41002, Russia

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