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A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival (VIALE-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04102020
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : November 14, 2019
Information provided by (Responsible Party):

Brief Summary:
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study takes place in 2 parts evaluating improvement in relapse-free survival (RFS): Part 1 (Dose confirmation) and Part 2 (Randomization). Part 2 begins after safety is assessed in Part 1 for approximately 4 weeks. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Venetoclax Drug: Azacitidine Other: Best Supportive Care (BSC) Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Estimated Study Start Date : January 18, 2020
Estimated Primary Completion Date : September 10, 2024
Estimated Study Completion Date : May 17, 2025

Arm Intervention/treatment
Experimental: Part 1: Venetoclax + Azacitidine (AZA)
Participants will be administered with venetoclax 400 mg once daily (QD) (Days 1-28) up to 24 cycles and azacitidine (AZA) 50 mg/m^2 QD on Days 1-5 of each 28 day cycle up to 6 cycles.
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199

Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection

Experimental: Part 2: Arm A: Venetoclax + Azacitidine (AZA)
Participants will be administered with venetoclax 400 mg QD (Days 1-28) up to 24 cycles and azacitidine (AZA) 50 mg/m^2, on Days 1-5 of each 28-day cycle up to 6 cycles
Drug: Venetoclax
Tablet: Oral
Other Names:
  • ABT-199
  • GDC-0199

Drug: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection

Experimental: Part 2: Arm B: Best Supportive Care (BSC)
Participants will receive treatment as prescribed by their physician according to the best supportive care for up to 24 cycles (1 cycle = 28 days)
Other: Best Supportive Care (BSC)
BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.

Primary Outcome Measures :
  1. Relapse-Free Survival (RFS) [ Time Frame: Time from treatment to relapse or death from any cause, up to approximately 3 years ]
    RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Time from treatment to relapse or 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.

  2. Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) [ 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.

  3. 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. [ 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."

  4. Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a [ 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".

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (2017) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of planned induction and consolidation chemotherapy.
    • Achieved first CR + CRi within 4 months of enrollment or be no more than 75 days since last dose of conventional therapy.
    • AML has intermediate or adverse 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04102020

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Contact: ABBVIE CALL CENTER 847.283.8955

Hide Hide 107 study locations
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United States, California
City of Hope /ID# 215672
Duarte, California, United States, 91010
UCSD Moores Cancer Center - LaJolla /ID# 216065
La Jolla, California, United States, 92093
United States, Kentucky
University of Kentucky Markey Cancer Center /ID# 215048
Lexington, Kentucky, United States, 40536-7001
Norton Cancer Institute /ID# 216401
Louisville, Kentucky, United States, 40202-3700
United States, Louisiana
Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Tufts Medical Center /ID# 216110
Boston, Massachusetts, United States, 02111
United States, Michigan
Univ Michigan Med Ctr /ID# 216524
Ann Arbor, Michigan, United States, 48109
United States, New York
Weill Cornell Medical College /ID# 214847
New York, New York, United States, 10021
Univ Rochester Med Ctr /ID# 215881
Rochester, New York, United States, 14642
United States, Pennsylvania
Thomas Jefferson University /ID# 214393
Philadelphia, Pennsylvania, United States, 19107-4414
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh, Pennsylvania, United States, 15232
Australia, New South Wales
St George Hospital /ID# 215416
Kogarah, New South Wales, Australia, 2217
Wollongong Hospital /ID# 216071
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Gold Coast University Hospital /ID# 214650
Southport, Queensland, Australia, 4215
Australia, Tasmania
Royal Hobart Hospital /ID# 215829
Hobart, Tasmania, Australia, 7000
Canada, Alberta
Tom Baker Cancer Centre /ID# 214625
Calgary, Alberta, Canada, T2N 4N2
University of Alberta Hospital /ID# 215656
Edmonton, Alberta, Canada, T6G 2G3
Canada, Ontario
Juravinski Hosp & Cancer Cntr /ID# 214623
Hamilton, Ontario, Canada, L8V 1C3
Princess Margaret Cancer Centre /ID# 214624
Toronto, Ontario, Canada, M5G 2M9
Fakultni nemocnice Plzen /ID# 214810
Plzeň 1, Plzen-jih, Czechia, 301 00
Fakultni nemocnice Ostrava /ID# 214809
Ostrava, Praha 5, Czechia, 708 52
Fakultni Nemocnice Brno /ID# 214807
Brno, Czechia, 625 00
Ustav Hematologie a krevni transfuze /ID# 215137
Prague 28, Czechia, 128 00
Centre Hospitalier Le Mans /ID# 215148
Le Mans CEDEX 9, Sarthe, France, 72037
CHU d'Angers /ID# 215151
Angers, France, 49933
Hopital Andre Mignot /ID# 215157
Le Chesnay, France, 78150
CHU Bordeaux /ID# 215150
Pessac, France, 33600
Universitaetsklinikum Leipzig /ID# 214440
Leipzig, Sachsen, Germany, 04103
Universitaetsklinikum Schleswig-Holstein /ID# 215173
Lübeck, Germany, 23538
Uniklinikum Giessen-Marburg Gm /ID# 214734
Marburg, Germany, 35043
General Hospital of Athens Laiko /ID# 213869
Athens, Attiki, Greece, 115 27
University General Hospital Attikon /ID# 214298
Athens, Attiki, Greece, 12462
Gen Univ Hosp Alexandroupolis /ID# 213870
Alexandroupolis, Greece, 68100
Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 213872
Athens, Greece, 115 21
University General Hospital of Heraklion "PA.G.N.I" /ID# 214075
Heraklion, Greece, 71110
Patras University General Hosp /ID# 213871
Rion, Patras, Achaia, Greece, 26504
Markusovszky Egyetemi Oktatokorhaz /ID# 215644
Szombathely, Vas, Hungary, 9700
Semmelweis Egyeteme III /ID# 214423
Budapest, Hungary, 1125
Debreceni Egyetem Klinikai Központ /ID# 214422
Debrecen, Hungary, 4032
Kaposi Mor Oktato Korhaz /ID# 214426
Kaposvar, Hungary, 7400
Szabolcs-Szatmar-Beregi /ID# 214425
Nyíregyhaza, Hungary, 4400
AOU Federico II /ID# 214278
Naples, Campania, Italy, 80131
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
Milano, Lombardia, Italy, 20162
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 214826
Milan, Lombardia, Italy, 20122
AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 213944
Ancona, Marche, Italy, 60126
AOU Citta della Salute Scienza /ID# 214505
Turin, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi /ID# 213948
Bologna, Italy, 40138
A.O. Spedali Civili Brescia /ID# 214580
Brescia, Italy, 25123
Azienda Ospedaliero Universita /ID# 214802
Catania, Italy, 95123
AORN A. Cardarelli /ID# 213947
Napoli, Italy, 80131
Ospedale S.Eugenio /ID# 214277
Rome, Italy, 00144
Aichi Cancer Center Hospital /ID# 215284
Nagoya-shi, Aichi, Japan, 464-8681
University of Fukui Hospital /ID# 215283
Yoshida-gun, Fukui, Japan, 910-1193
National Hospital Organization Kyushu Cancer Center /ID# 214841
Fukuoka-shi, Fukuoka, Japan, 811-1395
Kyushu University Hospital /ID# 215286
Fukuoka-shi, Fukuoka, Japan, 812-8582
National Hospital Organization Mito Medical Center /ID# 214699
Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
Hitachi General Hospital /ID# 214707
Hitachi-shi, Ibaraki, Japan, 317-0077
Tohoku University Hospital /ID# 214669
Sendai-shi, Miyagi, Japan, 980-8574
Nagasaki University Hospital /ID# 214916
Nagasaki-shi, Nagasaki, Japan, 852-8501
Okayama University Hospital /ID# 214840
Okayama-shi, Okayama, Japan, 700-8558
Kindai University Hospital /ID# 214915
Osaka-sayama, Osaka, Japan, 5898511
Osaka City University Hospital /ID# 215225
Osaka-shi, Osaka, Japan, 545-0051
Saitama Medical University International Medical Center /ID# 214823
Hidaka-shi, Saitama, Japan, 350-1298
NTT Medical Center Tokyo /ID# 214959
Shinagawa-ku, Tokyo, Japan, 141-8625
Yamagata University Hospital /ID# 214698
Yamagata-shi, Yamagata, Japan, 990-9585
JP Red Cross Nagoya Daiichi /ID# 215680
Nagoya, Japan, 453-8511
Hokkaido University Hospital /ID# 215938
Sapporo, Japan, 060-8648
Korea, Republic of
Pusan National University Hosp /ID# 213941
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Seoul National Univ Bundang ho /ID# 215549
Seongnam, Gyeonggido, Korea, Republic of, 13620
Samsung Medical Center /ID# 213940
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Seoul National University Hospital /ID# 213943
Seoul, Korea, Republic of, 03080
Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 214953
Rio Piedras, Puerto Rico, 00935
Russian Federation
Moscow State budget healthcare /ID# 214312
Moscow, Moskva, Russian Federation, 125284
Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 214309
Nizhnij Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 214315
Saratov, Saratovskaya Oblast, Russian Federation, 410012
City Clinical Hospital №40 /ID# 215223
Moscow, Russian Federation, 129301
Russian Scientific and Research Institute of Hematology and Transfusiology /ID# 215007
Sankt-Peterburg, Russian Federation, 191024
Almazov North-West Federal Med /ID# 214306
Sankt-peterburg, Russian Federation, 197341
Yaroslavl Regional Clinic Hosp /ID# 214318
Yaroslavl, Russian Federation, 150062
Hospital Santa Creu i Sant Pau /ID# 214714
Barcelona, Spain, 08026
ICO l´Hosp- Hosp Duran Reynals /ID# 214715
Barcelona, Spain, 08907
Hospital Reina Sofia de Cordob /ID# 214786
Cordoba, Spain, 14004
Hospital Infanta Leonor /ID# 214843
Madrid, Spain, 28031
MD Anderson CC Madrid /ID# 214477
Madrid, Spain, 28033
Hospital Ramon y Cajal /ID# 214684
Madrid, Spain, 28036
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
Madrid, Spain, 28040
Hosp Uni Virgen de la Victoria /ID# 214713
Malaga, Spain, 29010
Complejo Hospitalario de Navar /ID# 214788
Pamplona, Spain, 31008
China Medical University Hosp /ID# 213952
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 213939
Taipei City, Taipei, Taiwan, 10002
Kaohsiung Medical University /ID# 213953
Kaohsiung, Taiwan, 80708
Linkou Chang Gung Memorial Ho /ID# 213951
Taoyuan City, Taiwan, 33305
Erciyes University Medical Fac /ID# 214240
Melikgazi, Kayseri, Turkey, 38030
Gulhane Askeri Tip Academy /ID# 214242
Ankara, Turkey, 06010
Ankara Univ Medical Faculty /ID# 214239
Ankara, Turkey, 6100
Istanbul University Cerrahpasa Medical Faculty /ID# 215525
Istanbul, Turkey, 34098
Karadeniz University /ID# 214241
Trabzon, Turkey, 61000
United Kingdom
Belfast City Hospital /ID# 215923
Belfast, United Kingdom, BT9 7AB
Heartlands Hospital /ID# 215910
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Onc Ct /ID# 215911
Bristol, United Kingdom, BS2 8ED
University Hospital of Wales /ID# 215906
Cardiff, United Kingdom, CF14 4EN
St. James University Hospital /ID# 215922
Leeds, United Kingdom, LS9 7TF
St Bartholomew's Hospital, Bar /ID# 215909
London, United Kingdom, EC1A 7BE
UCLH, University College Hospi /ID# 215921
London, United Kingdom, NW1 2PG
Guy's Hospital /ID# 215908
London, United Kingdom, SE1 9RT
Christie NHS Foundation Trust /ID# 215905
Manchester, United Kingdom, M20 4BX
Nottingham Univ Hospitals NHS /ID# 215904
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie Identifier: NCT04102020    
Other Study ID Numbers: M19-708
2019-002217-19 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.

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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
Keywords provided by AbbVie:
Acute myeloid leukemia (AML)
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors