A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

September 10, 2025 updated by: AbbVie

A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute myeloid leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the patient has, and the age of the patient when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to cytarabine works better than cytarabine on its own.

This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors), placebo-controlled, multicenter study in patients with AML who are 18 or more years old and have not been treated before. Patients who take part in this study should not be suitable for intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study which will take place at approximately 125 hospitals globally. In this study, 2/3 of patients will receive venetoclax every day with cytarabine and the remaining 1/3 will receive placebo (dummy) tablets with cytarabine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
211

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Cemic /Id# 159676
      • Córdoba, Argentina, 5000
        • Sanatorio Allende /ID# 159675
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle /ID# 160123
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital /ID# 160121
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital /ID# 160125
      • Melbourne, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 162920
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen /ID# 159566
    • Brussels Capital
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires Saint Luc /ID# 159567
  • Brazil
      • Porto Alegre, Brazil, 90470-150
        • Hospital do Cancer Mae de Deus /ID# 163416
      • São Paulo, Brazil, 08270-070
        • Casa de Saúde Santa Marcelina /ID# 163413
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034-000
        • Centro de Pesquisas Oncologicas /ID# 163567
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos /ID# 163568
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta Hospital /ID# 159646
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie /ID# 159782
      • Montreal, Quebec, Canada, H1T 2M4
        • Hospital Maisonneuve-Rosemont /ID# 159780
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Sacre Coeur Montreal /ID# 160982
  • China
      • Jinan, China, 250014
        • Qilu Hospital of Shandong Univ /ID# 167507
      • Wuhan, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital /ID# 167327
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical Univ Union Hosp /ID# 167321
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 170147
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province People's Hospital /ID# 167511
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hosp of Jilin Univ /ID# 167512
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong /ID# 167325
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital /ID# 167514
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni Nemocnice Brno /ID# 159247
      • Ostrava, Czechia, 708 52
        • Univ Hosp Ostrava-Poruba /ID# 159246
      • Prague, Czechia, 100 34
        • Fakult Nem Kralovske Vinohrady /ID# 159248
  • France
      • Bayonne, France, 64100
        • Centre Hospitalier de la Cote /ID# 159697
      • Pessac, France, 33600
        • CHU Bordeaux /ID# 159704
      • Vandœuvre-lès-Nancy, France, 54511
        • CHU De Nancy /ID# 159700
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud /ID# 159705
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier Le Mans /ID# 159702
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban /ID# 159569
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg /ID# 161760
    • Baden-Wurttemberg
      • Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
        • Schwarzwald-Baar-Klinikum /ID# 159571
  • Greece
      • Alexandroupoli, Greece, 68100
        • Gen Univ Hosp Alexandroupolis /ID# 157868
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869
      • Pátrai, Greece, 26504
        • University Gen Hosp of Patra /ID# 157871
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki George Papanikolaou /ID# 157867
    • Attica
      • Athens, Attica, Greece, 115 27
        • General Hospital of Athens Laiko /ID# 157870
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem I. Belklini /ID# 158180
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Koz /ID# 158178
      • Győr, Hungary, 9023
        • Petz Aladar Megyei Oktato Korh /ID# 161739
      • Kaposvár, Hungary, 7400
        • Kaposi Mor Oktato Korhaz /ID# 158175
      • Kecskemét, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz /ID# 160973
    • Budapest
      • Budapest IX, Budapest, Hungary, 1097
        • Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127
    • Pecs
      • Pécs, Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem /ID# 163161
  • Ireland
      • Dublin, Ireland, D09 XR63
        • Beaumont Hospital /ID# 162733
      • Galway, Ireland, H91 YR71
        • University Hospital Galway /ID# 162734
      • Limerick, Ireland, V94F858
        • University Hospital Limerick /ID# 162735
    • Dublin
      • Dublin, Dublin, Ireland, D08 E9P6
        • St. James's Hospital /ID# 162730
  • Japan
      • Akita, Japan, 100041
        • Akita University Hospital /ID# 160602
      • Hidaka, Japan, 350-1241
        • Saitama Med Univ Int Med Ctr /ID# 161308
      • Nagoya, Japan, 460-0001
        • NHO Nagoya Medical Center /ID# 159768
      • Shimotsuga, Japan, 321-0293
        • Dokkyo Medical University Hosp /ID# 159650
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 159781
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1193
        • University of Fukui Hospital /ID# 159770
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 159688
    • Gunma
      • Maebashi, Gunma, Japan, 371-0821
        • Gunmaken Saiseikai Maebashi Hospital /ID# 160597
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
        • National Hospital Organization Mito Medical Center /ID# 162988
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Kyoto Prefect Univ Med /ID# 160101
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital /ID# 161151
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital /ID# 160233
    • Osaka
      • Osaka, Osaka, Japan, 545-0051
        • Osaka City University Hospital /ID# 159722
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kinki University -Osakasayama Campus /ID# 160777
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital /ID# 160759
      • Komae-shi, Tokyo, Japan, 201-8601
        • Tokyo Jikei Daisan Hospital /ID# 159769
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo /ID# 160678
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 161223
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Instituto Nacional de Cancerol /ID# 159269
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Centro de Invest Clin Chapulte /ID# 162625
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64320
        • Hosp. Univ. Dr. Jose E. Gonz /ID# 159268
  • New Zealand
      • Auckland, New Zealand, 0622
        • North Shore Hospital /ID# 160132
      • Auckland, New Zealand, 2025
        • Middlemore Clinical Trials /ID# 160131
  • Norway
      • Grålum, Norway, 1714
        • Sykehuset Ostfold Kalnes /ID# 165632
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland University Hospital /ID# 165630
  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
        • VA Caribbean Healthcare System /ID# 158999
  • Russia
      • Moscow, Russia, 125284
        • City Clinical Hospital Botkina /ID# 164086
      • Saint Petersburg, Russia, 197341
        • Almazov North-West Federal Med /ID# 162170
      • Saint Petersburg, Russia, 198205
        • Saint Petersburg State Institu /ID# 162171
      • Samara, Russia, 443099
        • Samara State Medical Universit /ID# 164173
      • Saratov, Russia, 41002
        • saratov state medical /ID# 163130
      • Yaroslavl, Russia, 150062
        • Yaroslavl Regional Clinic Hosp /ID# 162172
    • Kemerovo Oblast
      • Kemerovo, Kemerovo Oblast, Russia, 650066
        • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russia, 390039
        • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Netcare Pretoria East Hospital /ID# 157373
      • Pretoria, Gauteng, South Africa, 0001
        • Tshwane District Hospital /ID# 157361
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital /ID# 162253
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 602-739
        • Pusan National University Hosp /ID# 158725
    • Daejeon Gwang Yeogsi
      • Junggu, Daejeon Gwang Yeogsi, South Korea, 35015
        • Chungnam National University Hospital /ID# 158726
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • Cath Univ Seoul St Mary's Hosp /ID# 158724
  • Spain
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor /ID# 161180
    • Valenciana
      • Valencia, Valenciana, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 161181
  • Taiwan
      • Kaohsiung City, Taiwan, 80708
        • Kaohsiung Medical University /ID# 161693
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • National Taiwan Univ Hosp /ID# 162781
      • Taipei City, Taipei, Taiwan, 11490
        • Tri-Service General Hospital /ID# 161683
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital /ID# 163534
      • Cardiff, United Kingdom, CF14 4EN
        • University Hospital of Wales /ID# 162726
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital /ID# 162727
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffit Cancer Center /ID# 164273
    • Kentucky
      • Louisville, Kentucky, United States, 40202-3700
        • Norton Cancer Institute /ID# 158998
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Univ of Pittsburgh Med Ctr /ID# 158997
    • Texas
      • Houston, Texas, United States, 77030
        • Univ TX, MD Anderson /ID# 159678
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center /ID# 161280
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System /ID# 164272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Venetoclax + Low Dose Cytarabine (LDAC)
Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
Drug: Venetoclax
tablet
Other Names:
  • Venclexta
  • ABT-199
Drug: Cytarabine
Subcutaneous injection
Other Names:
  • Ara-C
  • Arabinosylcytosine
  • Cytosar-U
Placebo Comparator: Placebo + LDAC
Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
Drug: Placebo
tablet
Drug: Cytarabine
Subcutaneous injection
Other Names:
  • Ara-C
  • Arabinosylcytosine
  • Cytosar-U

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.
From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML:

CR: No morphologic evidence of AML and absolute neutrophil count (ANC) ≥ 10³/μL (1,000/μL), platelets ≥ 10⁵/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, the CRi criteria are met.

Participants who had no IWG disease assessments were considered to be non-responders.
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator.

CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met:

  • Bone marrow with < 5% blasts and
  • Peripheral blood neutrophil count of > 0.5 × 10³/μL and
  • Peripheral blood platelet count of > 0.5 × 10⁵/μL and
  • A 1 week platelet transfusion-free period prior to the hematology lab collection.

Participants with no disease assessments were considered to be non-responders.
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2
Time Frame: Cycle 1, 28 days

The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML:

CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met.

Participants who had no IWG disease assessments were considered to be non-responders.
Cycle 1, 28 days
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2
Time Frame: Cycle 1, 28 days

The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) before initiation of Cycle 2 assessed by the investigator.

CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRh is a derived response based on bone marrow blast and hematology lab values, achieved when when the following criteria are met:

  • Bone marrow with < 5% blasts and
  • Peripheral blood neutrophil count of > 0.5 × 10³/μL and
  • Peripheral blood platelet count of > 0.5 × 10⁵/μL and
  • A 1-week platelet transfusion-free period prior to the hematology lab collection.

Participants with no disease assessments were considered to be non-responders.
Cycle 1, 28 days
Percentage of Participants With Complete Remission
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The complete remission rate is defined as the percentage of participants with complete remission (CR) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML. CR is defined as no morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

Participants who had no IWG disease assessments were considered to be non-responders.
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a
Time Frame: Baseline and Day 1 of Cycles 3, 5, 7, and 9
PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points.
Baseline and Day 1 of Cycles 3, 5, 7, and 9
Change From Baseline in Global Health Status / Quality of Life
Time Frame: Baseline and Day 1 of Cycles 3, 5, 7, and 9

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting).

The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
Baseline and Day 1 of Cycles 3, 5, 7, and 9
Event-free Survival (EFS)
Time Frame: From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria.

PD:

  • > 50% increase in marrow blasts (minimum 15% increase required if blasts < 30% at baseline); or persistent marrow blast > 70% for ≥ 3 months; without at least a 100% improvement in ANC to an absolute level > 0.5 × 10⁹/L, and/or platelets to > 50 × 10⁹/L non-transfused; or
  • 50% increase in peripheral blasts to > 25 × 10⁹/L; or
  • New extramedullary disease

Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy.
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence
Time Frame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
The post baseline red blood cell (RBC) transfusion independence rate was calculated as the percentage of participants who achieved RBC transfusion independence post baseline. RBC transfusion independence is defined as a period of at least 56 consecutive days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Percentage of Participants With Post Baseline Platelet Transfusion Independence
Time Frame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier.
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
Time Frame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
The rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
Time Frame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
The rate of conversion was calculated as the percentage of participants who were post-baseline platelet transfusion independent among participants who had a platelet transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). Platelet transfusion independence is defined as a period of at least 56 days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The percentage of participants with complete remission or complete remission with incomplete blood count recovery AND minimal residual disease (MRD) as assessed by the investigator. Response was based on the modified IWG response criteria for AML:

CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria are met.

MRD response (at lowest-point MRD value) was defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow, per European LeukemiaNet (ELN) recommendations.

Participants who had no disease or MRD assessments were considered to be non-responders.
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The percentage of participants with complete remission or complete remission with partial hematologic recovery (CRh) AND MRD response as assessed by the investigator.

CR is defined according to the modified IWG response criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRh is achieved when the following criteria are met:

  • Bone marrow with < 5% blasts and
  • Peripheral blood neutrophil count of > 0.5 × 10³/μL and
  • Peripheral blood platelet count of > 0.5 × 10⁵/μL and
  • A 1 week platelet transfusion-free period prior to the hematology lab collection.

MRD response (at lowest-point MRD value) was defined as less than 10-³ residual blasts per leukocyte measured in the bone marrow, per ELN recommendations.

Participants who had no disease or MRD assessments were considered to be non-responders.
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Overall Survival (OS) by Mutation Subgroups
Time Frame: From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.

Overall survival was analyzed in participants with the following molecular markers:

  • Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation
  • FMS (Feline McDonough Sarcoma)-like tyrosine kinase 3 (FLT3) mutation
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML:

CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria is met.

Participants who had no IWG disease assessments were considered to be non-responders.

Response was analyzed in participants with the following mutations:

  • Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation
  • FMS-like tyrosine kinase 3 (FLT3) mutation
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup
Time Frame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations:

  • Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation
  • FMS-like tyrosine kinase 3 (FLT3) mutation

CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

CRh is achieved when the following criteria are met:

  • Bone marrow with < 5% blasts and
  • Peripheral blood neutrophil count > 0.5 × 10³/μL and
  • Peripheral blood platelet count > 0.5 × 10⁵/μL and
  • A 1 week platelet transfusion-free period prior to hematology lab collection. Participants with no disease assessments were considered non-responders
Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-043
  • 2016-003900-30 (EudraCT Number)
  • 2024-513630-37-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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