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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Azacitidine
CC-486
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute myeloid leukemia (AML), Venetoclax, Azacitidine, CC-486, Maintenance Therapy, Conventional Chemotherapy, Best supportive care (BSC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 120days of first dose of study drug or be no more than 75 days since last dose of intensive conventional 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).

Sites / Locations

  • Mitchell Cancer Institute /ID# 216443
  • Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
  • University of California, Los Angeles /ID# 219149
  • Colorado Blood Cancer Institute /ID# 214280
  • St. Alphonsus Regional Medical /ID# 216424
  • Rush University Medical Center /ID# 218815
  • University of Kentucky Markey Cancer Center /ID# 215048
  • Norton Cancer Institute /ID# 216401
  • Tulane Medical Center - New Orleans /ID# 218166
  • Ochsner Clinic Foundation-New Orleans /ID# 214583
  • Tufts Medical Center /ID# 216110
  • Massachusetts General Hospital /ID# 217307
  • UMass Chan Medical School /ID# 218163
  • Saint Louis University Cancer Center /ID# 218164
  • Oncology Hematology Associates (OHA) - Springfield /ID# 216351
  • The John Theurer Cancer /ID# 215191
  • Rutgers Cancer Institute of New Jersey /ID# 239708
  • Weill Cornell Medical College /ID# 214847
  • Providence Portland Medical Ct /ID# 216231
  • Fox Chase Cancer Center /ID# 239372
  • UPMC Hillman Cancer Ctr /ID# 214051
  • Prisma Health Cancer Institute-Faris Road /ID# 216066
  • St Francis Cancer Center /ID# 216115
  • Gibbs Cancer Center & Research /ID# 216192
  • Tennessee Oncology-Nashville Centennial /ID# 218757
  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
  • University of Texas MD Anderson Cancer Center /ID# 225201
  • St George Hospital /ID# 215416
  • Liverpool Hospital /ID# 215415
  • Shoalhaven District Memorial Hospital /ID# 221973
  • Wollongong Hospital /ID# 216071
  • Gold coast University Hospital /ID# 214650
  • Toowoomba Hospital /ID# 217922
  • Princess Alexandra Hospital /ID# 238753
  • Royal Adelaide Hospital /ID# 238754
  • Box Hill Hospital /ID# 217622
  • Barwon Health /ID# 217921
  • Perth Blood Institute Ltd /ID# 217531
  • Tom Baker Cancer Centre /ID# 214625
  • University of Alberta Hospital - Division of Hematology /ID# 215656
  • Juravinski Cancer Centre /ID# 214623
  • London Health Sciences Center- University Hospital /ID# 216055
  • Ottawa Hospital Research Institute /ID# 214627
  • Princess Margaret Cancer Centre /ID# 214624
  • McGill University Health Center Research Institute /ID# 215984
  • Beijing Friendship Hospital /ID# 216455
  • Chinese PLA General Hospital /ID# 216286
  • Guangdong Provincial People's Hospital /ID# 216284
  • Nanfang Hospital of Southern Medical University /ID# 215565
  • Henan Cancer Hospital /ID# 215566
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
  • Tongji Hospital Tongji Medical College of HUST /ID# 216456
  • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
  • Shanghai Tongji Hospital /ID# 218800
  • West China Hospital, Sichuan University /ID# 216606
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
  • Peking University International Hospital /ID# 217439
  • Fakultni Nemocnice Brno /ID# 214807
  • Fakultni nemocnice Ostrava /ID# 214809
  • Ustav hematologie a krevni transfuze /ID# 215137
  • CHU de Nice - Hôpital Archet 1 /ID# 217368
  • CHU Bordeaux - Hopital Haut Leveque /ID# 215150
  • CHRU Lille - Hopital Claude Huriez /ID# 217474
  • Hopital Avicenne - APHP /ID# 215152
  • CHRU Tours - Hopital Bretonneau /ID# 216186
  • CHU de Nantes - Hotel Dieu /ID# 217367
  • Centre Hospitalier de la Cote Basque /ID# 216185
  • Centre Hospitalier du Mans /ID# 215148
  • Institut Gustave Roussy /ID# 215158
  • Chu Angers /Id# 215151
  • Hopital Henri Mondor /ID# 215159
  • Centre Hospitalier de Versailles André Mignot /ID# 215157
  • Universitaetsklinikum Leipzig /ID# 214440
  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
  • Klinikum Chemnitz gGmbH /ID# 216073
  • Universitaetsklinikum Halle (Saale) /ID# 221109
  • Universitaetsklinikum Giessen und Marburg /ID# 214734
  • General Hospital of Athens Laiko /ID# 213869
  • University General Hospital Attikon /ID# 214298
  • University General Hospital of Heraklion PA.G.N.I /ID# 214075
  • General University Hospital of Alexandroupolis /ID# 213870
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
  • University General Hospital of Patras /ID# 213871
  • Debreceni Egyetem Klinikai Kozpont /ID# 214422
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
  • Markusovszky Egyetemi Oktatokorhaz /ID# 215644
  • Semmelweis Egyetem /ID# 214423
  • Tel Aviv Sourasky Medical Center /ID# 239698
  • Hadassah Medical Center-Hebrew University /ID# 239700
  • Shaare Zedek Medical Center /ID# 239699
  • Rabin Medical Center /ID# 239696
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948
  • ASST Spedali civili di Brescia /ID# 214580
  • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
  • ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
  • Azienda Ospedaliera Universitaria Federico II /ID# 214278
  • Ospedale S.Eugenio /ID# 214277
  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505
  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
  • Aichi Cancer Center Hospital /ID# 215284
  • University of Fukui Hospital /ID# 215283
  • National Hospital Organization Kyushu Cancer Center /ID# 214841
  • Kyushu University Hospital /ID# 215286
  • Hokkaido University Hospital /ID# 215938
  • National Hospital Organization Mito Medical Center /ID# 214699
  • Tohoku University Hospital /ID# 214669
  • Nagasaki University Hospital /ID# 214916
  • Okayama University Hospital /ID# 214840
  • Osaka Metropolitan University Hospital /ID# 215225
  • Kindai University Hospital /ID# 214915
  • Saitama Medical University International Medical Center /ID# 214823
  • NTT Medical Center Tokyo /ID# 214959
  • Yamagata University Hospital /ID# 214698
  • Seoul National University Bundang Hospital /ID# 215549
  • Pusan National University Hospital /ID# 213941
  • Seoul National University Hospital /ID# 213943
  • Samsung Medical Center /ID# 213940
  • Pan American Center for Oncology Trials, LLC /ID# 214953
  • Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
  • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
  • P. Hertsen Moscow Oncology Research Institute /ID# 214312
  • MMCC Kommunarka /ID# 215223
  • Clinic of Immunopathology, SRIFCI /ID# 217937
  • Almazov National Medical Research Centre /ID# 214306
  • Regional Clinical Hospital of Yaroslavl /ID# 214318
  • Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
  • Hospital Universitario de Navarra /ID# 214788
  • Hospital Santa Creu i Sant Pau /ID# 214714
  • Hospital Universitario Reina Sofia /ID# 214786
  • Hospital Universitario Infanta Leonor /ID# 214843
  • MD Anderson Madrid /ID# 214477
  • Hospital Universitario Ramon y Cajal /ID# 214684
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
  • Hospital Universitario 12 de Octubre /ID# 214789
  • Hospital Universitario Virgen de la Victoria /ID# 214713
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
  • China Medical University Hospital /ID# 213952
  • National Taiwan University Hospital /ID# 213939
  • Linkou Chang Gung Memorial Hospital /ID# 213951
  • Erciyes University Medical Fac /ID# 214240
  • Gulhane Askeri Tip Academy /ID# 214242
  • Ankara Univ Medical Faculty /ID# 214239
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525
  • Karadeniz University /ID# 214241
  • University Hospitals Bristol /ID# 215911
  • Leicester Royal Infirmary /ID# 215924
  • Barts Health NHS Trust /ID# 215909
  • Guys and St Thomas NHS Foundation Trust /ID# 215908
  • Cardiff & Vale University Health Board /ID# 215906
  • University Hospitals Birmingham NHS Foundation Trust /ID# 215910
  • University College London Hospitals NHS Foundation Trust /ID# 215921

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1: Dose Confirmation

Part 3 (Dose Finding): Dose Escalation

Part 3 (Dose Finding): Safety Expansion

Arm Description

Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 48 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.

Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).

Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.

Outcomes

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 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.
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)
DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2019
Last Updated
October 23, 2023
Sponsor
AbbVie
Collaborators
Roche-Genentech
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1. Study Identification

Unique Protocol Identification Number
NCT04102020
Brief Title
A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Acronym
VIALE-M
Official Title
A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2020 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Roche-Genentech

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
Acute myeloid leukemia (AML), Venetoclax, Azacitidine, CC-486, Maintenance Therapy, Conventional Chemotherapy, Best supportive care (BSC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Confirmation
Arm Type
Experimental
Arm Description
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 48 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Arm Title
Part 3 (Dose Finding): Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Arm Title
Part 3 (Dose Finding): Safety Expansion
Arm Type
Experimental
Arm Description
Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, Venclexta
Intervention Description
Tablet: Oral
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Subcutaneous (SC) or intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
CC-486
Other Intervention Name(s)
Azacitidine
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)
Description
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.
Time Frame
Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months
Title
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)
Description
DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.
Time Frame
Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Mitchell Cancer Institute /ID# 216443
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-7501
Country
United States
Facility Name
University of California, Los Angeles /ID# 219149
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Colorado Blood Cancer Institute /ID# 214280
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Alphonsus Regional Medical /ID# 216424
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Rush University Medical Center /ID# 218815
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kentucky Markey Cancer Center /ID# 215048
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-7001
Country
United States
Facility Name
Norton Cancer Institute /ID# 216401
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3700
Country
United States
Facility Name
Tulane Medical Center - New Orleans /ID# 218166
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2600
Country
United States
Facility Name
Ochsner Clinic Foundation-New Orleans /ID# 214583
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts Medical Center /ID# 216110
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Massachusetts General Hospital /ID# 217307
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
UMass Chan Medical School /ID# 218163
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Saint Louis University Cancer Center /ID# 218164
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-2539
Country
United States
Facility Name
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-5287
Country
United States
Facility Name
The John Theurer Cancer /ID# 215191
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey /ID# 239708
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Weill Cornell Medical College /ID# 214847
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Providence Portland Medical Ct /ID# 216231
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Fox Chase Cancer Center /ID# 239372
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Hillman Cancer Ctr /ID# 214051
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Prisma Health Cancer Institute-Faris Road /ID# 216066
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4255
Country
United States
Facility Name
St Francis Cancer Center /ID# 216115
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607-5253
Country
United States
Facility Name
Gibbs Cancer Center & Research /ID# 216192
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303-3040
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 218757
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 225201
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St George Hospital /ID# 215416
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital /ID# 215415
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Shoalhaven District Memorial Hospital /ID# 221973
City
Nowra
State/Province
New South Wales
ZIP/Postal Code
2541
Country
Australia
Facility Name
Wollongong Hospital /ID# 216071
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Gold coast University Hospital /ID# 214650
City
SouthPort
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Toowoomba Hospital /ID# 217922
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Princess Alexandra Hospital /ID# 238753
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 238754
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital /ID# 217622
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Barwon Health /ID# 217921
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Perth Blood Institute Ltd /ID# 217531
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Tom Baker Cancer Centre /ID# 214625
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta Hospital - Division of Hematology /ID# 215656
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Juravinski Cancer Centre /ID# 214623
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
London Health Sciences Center- University Hospital /ID# 216055
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 214627
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 214624
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Center Research Institute /ID# 215984
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Beijing Friendship Hospital /ID# 216455
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Chinese PLA General Hospital /ID# 216286
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Guangdong Provincial People's Hospital /ID# 216284
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 215565
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Henan Cancer Hospital /ID# 215566
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 216456
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Shanghai Tongji Hospital /ID# 218800
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 216606
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Peking University International Hospital /ID# 217439
City
Beijing
ZIP/Postal Code
102206
Country
China
Facility Name
Fakultni Nemocnice Brno /ID# 214807
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 214809
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Ustav hematologie a krevni transfuze /ID# 215137
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
CHU de Nice - Hôpital Archet 1 /ID# 217368
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 215150
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 217474
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Avicenne - APHP /ID# 215152
City
Bobigny
State/Province
Ile-de-France
ZIP/Postal Code
93000
Country
France
Facility Name
CHRU Tours - Hopital Bretonneau /ID# 216186
City
Tours CEDEX 9
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Nantes - Hotel Dieu /ID# 217367
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier de la Cote Basque /ID# 216185
City
Bayonne
State/Province
Pyrenees-Atlantiques
ZIP/Postal Code
64100
Country
France
Facility Name
Centre Hospitalier du Mans /ID# 215148
City
Le Mans CEDEX 9
State/Province
Sarthe
ZIP/Postal Code
72037
Country
France
Facility Name
Institut Gustave Roussy /ID# 215158
City
Villejuif Cedex
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Chu Angers /Id# 215151
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Henri Mondor /ID# 215159
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Hospitalier de Versailles André Mignot /ID# 215157
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Universitaetsklinikum Leipzig /ID# 214440
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH /ID# 216073
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 221109
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg /ID# 214734
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
General Hospital of Athens Laiko /ID# 213869
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital Attikon /ID# 214298
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 214075
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General University Hospital of Alexandroupolis /ID# 213870
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Patras /ID# 213871
City
RION Patras Achaia
ZIP/Postal Code
26504
Country
Greece
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 214422
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz /ID# 215644
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 214423
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Tel Aviv Sourasky Medical Center /ID# 239698
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 239700
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 239699
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center /ID# 239696
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Spedali civili di Brescia /ID# 214580
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II /ID# 214278
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S.Eugenio /ID# 214277
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Aichi Cancer Center Hospital /ID# 215284
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
University of Fukui Hospital /ID# 215283
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center /ID# 214841
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital /ID# 215286
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 215938
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 214699
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Tohoku University Hospital /ID# 214669
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 214916
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Okayama University Hospital /ID# 214840
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 215225
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital /ID# 214915
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical University International Medical Center /ID# 214823
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 214959
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Yamagata University Hospital /ID# 214698
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Seoul National University Bundang Hospital /ID# 215549
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 213941
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 213943
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 213940
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Pan American Center for Oncology Trials, LLC /ID# 214953
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
P. Hertsen Moscow Oncology Research Institute /ID# 214312
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
MMCC Kommunarka /ID# 215223
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Clinic of Immunopathology, SRIFCI /ID# 217937
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre /ID# 214306
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Regional Clinical Hospital of Yaroslavl /ID# 214318
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario de Navarra /ID# 214788
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 214714
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia /ID# 214786
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor /ID# 214843
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
MD Anderson Madrid /ID# 214477
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 214684
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 214789
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 214713
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 213952
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 213939
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 213951
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Erciyes University Medical Fac /ID# 214240
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Gulhane Askeri Tip Academy /ID# 214242
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 214239
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Karadeniz University /ID# 214241
City
Trabzon
ZIP/Postal Code
61000
Country
Turkey
Facility Name
University Hospitals Bristol /ID# 215911
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Leicester Royal Infirmary /ID# 215924
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 215909
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 215908
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 215906
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 215921
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, analyses plans, 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
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35852098
Citation
Ivanov V, Yeh SP, Mayer J, Saini L, Unal A, Boyiadzis M, Hoffman DM, Kang K, Addo SN, Mendes WL, Fathi AT. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. Future Oncol. 2022 Aug;18(26):2879-2889. doi: 10.2217/fon-2022-0450. Epub 2022 Jul 19.
Results Reference
derived
PubMed Identifier
33394722
Citation
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-708
Description
Related Info

Learn more about this trial

A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

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