Clinical trial NCT04102020: 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
Official title: Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute myeloid leukemia (AML)
Venetoclax
Azacitidine (AZA)
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Roche-Genentech
First posted: 2019-09-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.


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).

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (AZA) (Part 1)
timeFrame: Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months
measure: Number of Participants With DLTs of Venetoclax in Combination with Oral AZA (Part 3 Dose Finding Portion)
timeFrame: Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mitchell Cancer Institute /ID# 216443
state: Alabama
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 219149
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute /ID# 214280
state: Colorado
city: Boise
country: United States
facility: St. Alphonsus Regional Medical /ID# 216424
state: Idaho
city: Chicago
country: United States
facility: Duplicate_Rush University Medical Center /ID# 218815
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center /ID# 215048
state: Kentucky
city: Louisville
country: United States
facility: Duplicate_Norton Cancer Institute /ID# 216401
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center - New Orleans /ID# 218166
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation-New Orleans /ID# 214583
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center /ID# 216110
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 217307
state: Massachusetts
city: Worcester
country: United States
facility: Duplicate_UMass Chan Medical School /ID# 218163
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center /ID# 218164
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates (OHA) - Springfield /ID# 216351
state: Missouri
city: Hackensack
country: United States
facility: The John Theurer Cancer /ID# 215191
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey /ID# 239708
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 214847
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Ct /ID# 216231
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center /ID# 239372
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 214051
state: Pennsylvania
city: Greenville
country: United States
facility: Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
state: South Carolina
city: Greenville
country: United States
facility: St Francis Cancer Center /ID# 216115
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Cancer Center & Research /ID# 216192
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 218757
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 225201
state: Texas
city: Kogarah
country: Australia
facility: St George Hospital /ID# 215416
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 215415
state: New South Wales
city: Nowra
country: Australia
facility: Shoalhaven District Memorial Hospital /ID# 221973
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital /ID# 216071
state: New South Wales
city: SouthPort
country: Australia
facility: Gold coast University Hospital /ID# 214650
state: Queensland
city: Toowoomba
country: Australia
facility: Toowoomba Hospital /ID# 217922
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 238753
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 238754
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital /ID# 217622
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health /ID# 217921
state: Victoria
city: Nedlands
country: Australia
facility: Perth Blood Institute Ltd /ID# 217531
state: Western Australia
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre /ID# 214625
state: Alberta
city: Edmonton
country: Canada
facility: Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 214623
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 216055
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 214627
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 214624
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center Research Institute /ID# 215984
state: Quebec
city: Beijing
country: China
facility: Beijing Friendship Hospital /ID# 216455
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 216286
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 216284
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 215565
state: Guangdong
city: Beijing
country: China
facility: Peking University International Hospital /ID# 217439
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 215566
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 216456
state: Hubei
city: Shanghai
country: China
facility: Duplicate_Shanghai Tongji Hospital /ID# 218800
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 216606
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
state: Zhejiang
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 214809
state: Praha 17
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno /ID# 214807
city: Praha
country: Czechia
facility: Ustav hematologie a krevni transfuze /ID# 215137
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet 1 /ID# 217368
state: Alpes-Maritimes
city: Pessac
country: France
facility: Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
state: Gironde
city: Bobigny
country: France
facility: Hopital Avicenne - APHP /ID# 215152
state: Ile-de-France
city: Tours CEDEX 9
country: France
facility: CHRU Tours - Hopital Bretonneau /ID# 216186
state: Indre-et-Loire
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 217474
state: Nord
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu /ID# 217367
state: Pays-de-la-Loire
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque /ID# 216185
state: Pyrenees-Atlantiques
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 215148
state: Sarthe
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy /ID# 215158
state: Val-de-Marne
city: Angers
country: France
facility: Chu Angers /Id# 215151
city: Creteil
country: France
facility: Duplicate_Hopital Henri Mondor /ID# 215159
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot /ID# 215157
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH /ID# 216073
state: Saarland
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg /ID# 214734
state: Saarland
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 214440
state: Sachsen
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
state: Schleswig-Holstein
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 221109
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 213869
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 214298
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 214075
state: Kriti
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 213870
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 213871
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 214422
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
state: Szabolcs-Szatmar-Bereg
city: Szombathely
country: Hungary
facility: Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 214423
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 239698
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 239699
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 239700
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 239696
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 214278
state: L Aquila
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
state: Milano
city: Torino
country: Italy
facility: AOU Citta della Salute e della Scienza di Torino /ID# 214505
state: Piemonte
city: Ancona
country: Italy
facility: Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948
city: Brescia
country: Italy
facility: ASST Spedali civili di Brescia /ID# 214580
city: Catania
country: Italy
facility: Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
city: Rome
country: Italy
facility: Ospedale S.Eugenio /ID# 214277
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 215284
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 215283
state: Fukui
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 214841
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 215286
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 215938
state: Hokkaido
city: Higashi Ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center /ID# 214699
state: Ibaraki
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 214669
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 214916
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Duplicate_Okayama University Hospital /ID# 214840
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 215225
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 214915
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center /ID# 214823
state: Saitama
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 214959
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 214698
state: Yamagata
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 213941
state: Busan Gwang Yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 215549
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 213943
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 213940
state: Seoul Teugbyeolsi
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 214953
city: Novosibirsk
country: Russian Federation
facility: Clinic of Immunopathology, SRIFCI /ID# 217937
state: Kurskaya Oblast
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Hospital of Yaroslavl /ID# 214318
state: Kurskaya Oblast
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
state: Nizhegorodskaya Oblast
city: St. Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
state: Sankt-Peterburg
city: Moscow
country: Russian Federation
facility: P. Hertsen Moscow Oncology Research Institute /ID# 214312
city: Moscow
country: Russian Federation
facility: MMCC Kommunarka /ID# 215223
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 214306
city: Hospitalet de Llobregat
country: Spain
facility: Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra /ID# 214788
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 214714
city: Cordoba
country: Spain
facility: Duplicate_Hospital Universitario Reina Sofia /ID# 214786
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor /ID# 214843
city: Madrid
country: Spain
facility: MD Anderson Madrid /ID# 214477
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 214684
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 214789
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 214713
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
state: Keelung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 213939
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 213952
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 213951
city: Ankara
country: Turkey
facility: Gulhane Askeri Tip Academy /ID# 214242
state: Adana
city: Trabzon
country: Turkey
facility: Karadeniz University /ID# 214241
state: Adana
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 214239
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty /ID# 214240
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol /ID# 215911
state: Bristol, City Of
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 215924
state: England
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 215909
state: London, City Of
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 215908
state: London, City Of
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board /ID# 215906
state: Wales
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 215910
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust /ID# 215921
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
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.
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.