A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

March 20, 2026 updated by: AbbVie

Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Expanded Access

Available 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

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital /ID# 215416
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital /ID# 215415
      • Nowra, New South Wales, Australia, 2541
        • Shoalhaven District Memorial Hospital /ID# 221973
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital /ID# 216071
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold coast University Hospital /ID# 214650
      • Toowoomba, Queensland, Australia, 4350
        • Toowoomba Hospital /ID# 217922
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital /ID# 238753
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital /ID# 238754
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 217622
      • Geelong, Victoria, Australia, 3220
        • Barwon Health /ID# 217921
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perth Blood Institute Ltd /ID# 217531
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre /ID# 214625
      • Edmonton, Alberta, Canada, T6G 2B7
        • Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre /ID# 214623
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center- University Hospital /ID# 216055
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute /ID# 214627
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network_Princess Margaret Cancer Centre /ID# 214624
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Duplicate_McGill University Health Center Research Institute /ID# 215984
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100032
        • Beijing Friendship Hospital /ID# 216455
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital /ID# 216286
      • Beijing, Beijing Municipality, China, 102206
        • Peking University International Hospital /ID# 217439
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital /ID# 216284
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 215565
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital /ID# 215566
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical College of HUST /ID# 216456
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Duplicate_Shanghai Tongji Hospital /ID# 218800
    • Shanxi
      • Xi’an, Shanxi, China, 710038
        • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 216606
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
  • Czechia
      • Prague, Czechia, 128 00
        • Ustav hematologie a krevni transfuze /ID# 215137
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 625 00
        • Fakultní Nemocnice Brno - Jihlavská /ID# 214807
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 708 52
        • Fakultni Nemocnice Ostrava /ID# 214809
  • France
      • Angers, France, 49933
        • Chu Angers /Id# 215151
      • Créteil, France, 94000
        • Duplicate_Hopital Henri Mondor /ID# 215159
      • Le Chesnay, France, 78150
        • Centre Hospitalier de Versailles André Mignot /ID# 215157
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Chu de Nice-Hopital L'Archet Ii /Id# 217368
    • Gironde
      • Pessac, Gironde, France, 33604
        • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • CHRU Tours - Hopital Bretonneau /ID# 216186
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 217474
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Duplicate_CHU de Nantes - Hotel Dieu /ID# 217367
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Centre Hospitalier de la Cote Basque /ID# 216185
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 215148
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Institut Gustave Roussy /ID# 215158
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
        • Hopital Avicenne - APHP /ID# 215152
  • Germany
      • Halle, Germany, 06120
        • Universitaetsklinikum Halle (Saale) /ID# 221109
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Universitaetsklinikum Giessen und Marburg /ID# 214734
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Duplicate_Klinikum Chemnitz gGmbH /ID# 216073
      • Leipzig, Saxony, Germany, 04103
        • Universitaetsklinikum Leipzig /ID# 214440
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
  • Greece
      • Alexandroupoli, Greece, 68100
        • General University Hospital of Alexandroupolis /ID# 213870
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
      • RION Patras Achaia, Greece, 26504
        • University General Hospital of Patras /ID# 213871
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 213869
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 214298
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 214075
  • Hungary
      • Budapest, Hungary, 1085
        • Duplicate_Semmelweis Egyetem /ID# 214423
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 214422
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
  • Israel
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 239696
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 239699
      • Jerusalem, Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 239700
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 239698
  • Italy
      • Ancona, Italy, 60126
        • Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia /ID# 214580
      • Catania, Italy, 95123
        • Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
      • Naples, Italy, 80131
        • Duplicate_Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
      • Naples, Italy, 80131
        • Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 214278
      • Rome, Italy, 00144
        • Ospedale S.Eugenio /ID# 214277
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 213948
    • Milano
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
      • Milan, Milano, Italy, 20122
        • Duplicate_Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 214505
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 453-8511
        • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center Hospital /ID# 215284
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1104
        • University of Fukui Hospital /ID# 215283
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 215286
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Duplicate_Hokkaido University Hospital /ID# 215938
    • Ibaraki
      • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
        • Duplicate_National Hospital Organization Mito Medical Center /ID# 214699
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 214669
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Duplicate_Nagasaki University Hospital /ID# 214916
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Duplicate_Okayama University Hospital /ID# 214840
    • Osaka
      • Osaka, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 215225
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital /ID# 214915
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center /ID# 214823
    • Tokyo
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo /ID# 214959
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital /ID# 214698
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Center for Oncology Trials, LLC /ID# 214953
  • Russia
      • Moscow, Russia, 125284
        • P. Hertsen Moscow Oncology Research Institute /ID# 214312
      • Moscow, Russia, 129301
        • MMCC Kommunarka /ID# 215223
      • Saint Petersburg, Russia, 197341
        • Almazov National Medical Research Centre /ID# 214306
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630047
        • Clinic of Immunopathology, SRIFCI /ID# 217937
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197101
        • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
    • Tatarstan, Respublika
      • Yaroslavl, Tatarstan, Respublika, Russia, 150062
        • Regional Clinical Hospital of Yaroslavl /ID# 214318
  • South Korea
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Duplicate_Pusan National University Hospital /ID# 213941
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 215549
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 213943
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 213940
  • Spain
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 214714
      • Córdoba, Spain, 14004
        • Duplicate_Hospital Universitario Reina Sofia /ID# 214786
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor /ID# 214843
      • Madrid, Spain, 28033
        • MD Anderson Madrid /ID# 214477
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 214684
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 214789
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria /ID# 214713
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Duplicate_Hospital Universitario de Navarra /ID# 214788
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 213952
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 213951
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 213939
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Askeri Tip Academy /ID# 214242
      • Ankara, Turkey (Türkiye), 06590
        • Ankara Univ Medical Faculty /ID# 214239
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes University Medical Faculty /ID# 214240
      • Trabzon, Turkey (Türkiye), 61000
        • Karadeniz University /ID# 214241
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 215910
      • Bristol, United Kingdom, BS1 3NU
        • University Hospitals Bristol /ID# 215911
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary /ID# 215924
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
      • London, Greater London, United Kingdom, NW1 2PG
        • Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
      • London, Greater London, United Kingdom, SE1 9RT
        • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • Cardiff & Vale University Health Board /ID# 215906
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Mitchell Cancer Institute /ID# 216443
    • California
      • Fountain Valley, California, United States, 92708-7501
        • Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles /ID# 219149
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute /ID# 214280
    • Idaho
      • Boise, Idaho, United States, 83706
        • St. Alphonsus Regional Medical /ID# 216424
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Duplicate_Rush University Medical Center /ID# 218815
    • Kentucky
      • Lexington, Kentucky, United States, 40536-7001
        • University of Kentucky Markey Cancer Center /ID# 215048
      • Louisville, Kentucky, United States, 40202-3700
        • Duplicate_Norton Cancer Institute /ID# 216401
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2600
        • Tulane Medical Center - New Orleans /ID# 218166
      • New Orleans, Louisiana, United States, 70121
        • Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1552
        • Tufts Medical Center /ID# 216110
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 217307
      • Worcester, Massachusetts, United States, 01655
        • Duplicate_UMass Chan Medical School /ID# 218163
    • Missouri
      • Springfield, Missouri, United States, 65807-5287
        • Oncology Hematology Associates (OHA) - Springfield /ID# 216351
      • St Louis, Missouri, United States, 63110-2539
        • Saint Louis University Cancer Center /ID# 218164
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The John Theurer Cancer /ID# 215191
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey /ID# 239708
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College /ID# 214847
    • Oregon
      • Portland, Oregon, United States, 97213-2933
        • Providence Portland Medical Ct /ID# 216231
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center /ID# 239372
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Ctr /ID# 214051
    • South Carolina
      • Greenville, South Carolina, United States, 29607-5253
        • St Francis Cancer Center /ID# 216115
      • Greenville, South Carolina, United States, 29605-4255
        • Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
      • Spartanburg, South Carolina, United States, 29303-3040
        • Gibbs Cancer Center & Research /ID# 216192
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1632
        • Tennessee Oncology-Nashville Centennial /ID# 218757
    • Texas
      • Dallas, Texas, United States, 75246-2003
        • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center /ID# 225201

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of newly diagnosed acute myeloid leukemia (AML).

  • Participant meets the following disease activity criteria:

    • Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
    • Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
    • AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
  • Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

  • History of acute promyelocytic leukemia (APL).
  • History of active central nervous system involvement with acute myeloid leukemia (AML).

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Confirmation
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Drug: Venetoclax
Tablet: Oral
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: Azacitidine
Oral Tablet
Experimental: Part 3 (Dose Finding): Dose Escalation
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Drug: Venetoclax
Tablet: Oral
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: Azacitidine
Oral Tablet
Experimental: Part 3 (Dose Finding): Safety Expansion
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Drug: Venetoclax
Tablet: Oral
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: Azacitidine
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1)
Time Frame: Up to 28 days (Cycle 1)
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Up to 28 days (Cycle 1)
Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion)
Time Frame: Up to 28 days (Cycle 1)
DLTs are hematologic toxicities consisting of any Grade ≥ 3 neutropenia or thrombocytopenia lasting more than 7 days and nonhematologic toxicities as described in the protocol and evaluated by the Investigator and the Sponsor. In addition, AEs that lead to omitting > 20% of the scheduled dose within the cycle is considered as a DLT unless clearly related to underlying disease. Treatment delay due to toxicity lasting greater than 14 days since the last dose of Venetoclax is also considered a DLT.
Up to 28 days (Cycle 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) (Part 3 Randomization Portion)
Time Frame: Time from treatment to death from any cause, up to approximately 3 years
OS is defined as the number of days from the date of randomization to the date of death.
Time from treatment to death from any cause, up to approximately 3 years
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) (Part 3 Randomization Portion)
Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.
Measured From Baseline to approximately 3.5 years after the first participant is randomized
Time to Deterioration in Global Health Status (GHS)/Quality-of Life (QoL) Score Based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30-Item (EORTC QLQ-C30) Scoring Manual (Part 3 Randomization Portion)
Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured From Baseline to approximately 3.5 years after the first participant is randomized
Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a (Part 3 Randomization Portion)
Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized
Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
Measured From Baseline to approximately 3.5 years after the first participant is randomized
Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 3 Randomization Portion)
Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured From Baseline to approximately 3.5 years after the first participant is randomized
Change From Baseline in Patient Reported Outcomes (PRO) in Items from European Quality-of-Life-5 Dimesional-5-Level (EQ5D5L) Between Arms A and B (Part 3 Randomization Portion)
Time Frame: Measured From Baseline to approximately 3.5 years after the first participant is randomized
The EQ5D5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Measured From Baseline to approximately 3.5 years after the first participant is randomized

Collaborators and Investigators

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

Sponsor

AbbVie

Collaborators

Roche-Genentech

Investigators

  • 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)

March 26, 2020

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

February 20, 2026

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-708
  • 2023-507221-42-00 (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 clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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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