Clinical trial NCT04161885: A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
Official title: A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Cancer
Keywords: Acute Myeloid Leukemia (AML)
Venetoclax
Azacitidine
Stem Cell Transplantation (SCT)
Best Support Care (BSC)
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 465
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).

This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
* Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days.
* Blast percentage in bone marrow before transplant must be \< 10%.
* Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be \< 5% after transplant.
* Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
* Participants \>= 17 years old must have a Karnofsky Performance Scale (KPS) score \> 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score \> 40.

Exclusion Criteria:

* History of disease progression during prior treatment with venetoclax.
* History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
* Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
timeFrame: Up to the first treatment cycle (28 days)
measure: Overall Survival (OS) (Part 2)
timeFrame: Up to 45 months after the first participant is randomized
Secondary outcomes:
measure: Morphologic Relapse-Free Survival (RFS) (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Composite Relapse-Free Survival (RFS) (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Graft-versus-Host Disease (GvHD) Rate (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Change From Randomization in Fatigue in Adult Participants (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
timeFrame: Up to 39 months after the first participant is randomized
measure: Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L)
timeFrame: Up to 39 months after the first participant is randomized
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center - Tucson /ID# 242507
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 239804
state: Arkansas
city: Duarte
country: United States
facility: City of Hope /ID# 213681
state: California
city: Aurora
country: United States
facility: UCHSC Anschultz Cancer Pavilion /ID# 215618
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute /ID# 215980
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 239710
state: Florida
city: Orlando
country: United States
facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 215616
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Ctr /ID# 215617
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood & Marrow Transpl /ID# 215842
state: Indiana
city: New Orleans
country: United States
facility: Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 213855
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 215765
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute - Dresner Clinic /ID# 214581
state: Michigan
city: Minneapolis
country: United States
facility: Masonic Cancer Center /ID# 239492
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 214685
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center /ID# 239343
state: Mississippi
city: Hackensack
country: United States
facility: The John Theurer Cancer /ID# 215251
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus /ID# 241669
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute /ID# 217857
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 240875
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 214887
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina /ID# 215814
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ HS /ID# 239210
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health - Cincinnati /ID# 239263
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals - Seidman Cancer Center /ID# 239260
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma, Stephenson Cancer Center /ID# 215611
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 215874
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Ctr /ID# 217120
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 215410
state: Pennsylvania
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine /ID# 214518
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duplicate_Allegheny General Hospital /ID# 216756
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 213715
state: Pennsylvania
city: Nashville
country: United States
facility: TriStar Centennial Medical Center /ID# 218750
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 216720
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute /ID# 214691
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 239203
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center /ID# 214436
state: Washington
city: Madison
country: United States
facility: Univ of Wisconsin Hosp/Clinics /ID# 216096
state: Wisconsin
city: Darlinghurst
country: Australia
facility: The Kinghorn Cancer Centre /ID# 214660
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 215678
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Ctr /ID# 214653
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 240931
state: Victoria
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 215042
state: Rio Grande Do Sul
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Nove de Julho /ID# 242359
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 239516
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network_Princess Margaret Cancer Centre /ID# 215344
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 215253
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre /ID# 238821
state: Saskatchewan
city: Beijing
country: China
facility: Peking University People's Hospital /ID# 215551
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 216287
state: Beijing
city: Beijing
country: China
facility: Aerospace Center Hospital /ID# 217018
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital /ID# 215555
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 218666
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University /ID# 216333
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 215553
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital /ID# 239401
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 215554
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University /ID# 219025
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 218926
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 216605
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College /ID# 239098
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 239168
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Changhai Hospital /ID# 216334
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282
state: Shanxi
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno - Jihlavská /ID# 214811
state: Brno-mesto
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 214814
state: Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 239922
state: Ostrava-mesto
city: Praha
country: Czechia
facility: Ustav hematologie a krevni transfuze /ID# 215133
city: Nice
country: France
facility: Duplicate_CHU de Nice - Hôpital Archet 1 /ID# 214056
state: Alpes-Maritimes
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 241171
state: Doubs
city: Pessac
country: France
facility: Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 214055
state: Gironde
city: Paris Cedex 13
country: France
facility: Hopital Pitie Salpetriere /ID# 241072
state: Ile-de-France
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 217916
state: Nord
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 214060
state: Pays-de-la-Loire
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 214054
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 216957
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 216623
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Klinikum Augsburg /ID# 239583
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg /ID# 215212
state: Bayern
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 215213
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 214244
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 245892
state: Sachsen
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 239585
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 214243
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos /ID# 238810
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 238812
state: Attiki
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 238811
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 241123
state: Hajdu-Bihar
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 214507
state: H_efa
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center /ID# 224326
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 239571
state: Tel-Aviv
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 214305
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 214508
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 218697
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 214509
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 214311
state: Milano
city: Milan
country: Italy
facility: Istituto Europeo Di Oncologia /ID# 242579
state: Milano
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 216148
state: Piemonte
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
state: Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
state: Roma
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 215997
city: Anjo-shi
country: Japan
facility: Anjou Kousei Hospital /ID# 215857
state: Aichi
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 253383
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 215285
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 252293
state: Fukushima
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 215937
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 215388
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 215389
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 242955
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: Imamura General Hospital /ID# 215688
state: Kagoshima
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 250086
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center /ID# 215029
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 243209
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 214670
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 214842
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 215227
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 214917
state: Osaka
city: Saitama-shi
country: Japan
facility: Jichi Medical University Saitama Medical Center /ID# 216092
state: Saitama
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital /ID# 216091
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 242639
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 215311
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 242479
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 243549
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 253304
state: Yamagata
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 214891
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 214893
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 239087
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892
state: Seoul Teugbyeolsi
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 215108
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 240397
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 215107
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 218102
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 218103
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 215463
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 215106
city: Basel
country: Switzerland
facility: Duplicate_Universitätsspital Basel /ID# 215892
state: Basel-Stadt
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 215891
state: Zuerich
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 215245
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 215198
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 239288
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 239289
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 215319
city: London
country: United Kingdom
facility: Hammersmith Hospital /ID# 215665
state: England
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital /ID# 215663
state: Glasgow City
city: London
country: United Kingdom
facility: University College London Hospital /ID# 215662
state: Greater London
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 215120
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 215338
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust /ID# 215124
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: