Clinical trial NCT02993523: A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Official title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia
Venetoclax
Treatment Naïve
Azacitidine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2016-12-15
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.

This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.

In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.


Eligibility criteria: Inclusion Criteria:

* Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.
* Participant must be \>= 18 years of age.
* Participant must have a projected life expectancy of at least 12 weeks.
* Participant must be considered ineligible for induction therapy defined by the following:

  a. \>= 75 years of age; or b. \>= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \<= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \<= 65% or Forced Expiratory Volume in 1 second (FEV1) \<= 65%; iv. Creatinine clearance \>= 30 mL/min to \< 45 ml/min; v. Moderate hepatic impairment with total bilirubin \> 1.5 to \<= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Medical Director during screening and before study enrollment.
* Participant must have an ECOG Performance status:

  1. 0 to 2 for Participants \>= 75 years of age or
  2. 0 to 3 for Participants \>= 18 to 74 years of age.
* Participant must have adequate renal function as demonstrated by a creatinine \>= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
* Participant must have adequate liver function as demonstrated by:

  1. aspartate aminotransferase (AST) \<= 3.0 x ULN\*
  2. alanine aminotransferase (ALT) \<= 3.0 x ULN\*
  3. bilirubin \<= 1.5 x ULN\* \* Unless considered to be due to leukemic organ involvement

  i. Participants who are \< 75 years of age may have a bilirubin of \<= 3.0 x ULN
* Female participants must be either postmenopausal defined as:

  1. Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
  2. Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an follicle stimulating hormone (FSH) level \>40 international units per liter (IU/L); or
  3. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); or
  4. Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day 1 through at least 90 days after the last dose of study drug.
* Male participants who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
* Female participants of childbearing potential must have negative results for pregnancy test performed:

  1. At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
  2. Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been \> 7 days since obtaining the serum pregnancy test results.
* Participant must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

* Participant has received treatment with the following:

  1. A hypomethylating agent, venetoclax and/or chemo therapeutic agent for Myelodysplastic syndrome (MDS).
  2. Chimeric Antigen Receptor (CAR)-T cell therapy.
  3. Experimental therapies for MDS or Acute Myeloid Leukemia (AML).
  4. Current participation in another research or observational study.
* Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
* Participant has the following:

  a. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
* Participant has acute promyelocytic leukemia
* Participant has known active central nervous system (CNS) involvement with AML.
* Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax) HIV testing will be performed at Screening, only if required per local guidelines or institutional standards.
* Participant is known to be positive for hepatitis B or C infection \[HCV Ab indicative of a previous or current infection; and/or positive HBs Ag or detected sensitivity on hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) test for HBc Ab and/or HBs Ab positivity\] with the exception of those with an undetectable viral load within 3 months screening. Hepatitis B or C testing is not required.
* Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment; additional details as described in the protocol.
* Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
* Participant has a cardiovascular disability status of New York Heart Association Class \> 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
* Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.
* Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
* Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
* Participant has a history of other malignancies within 2 years prior to study entry, with the exception of:

  1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
  2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  3. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; requires discussion with TA MD.
* Participant has a white blood cell count \> 25 × 10\^9/L. (Hydroxyurea or leukapheresis are permitted to meet this criterion.)

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
measure: Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
timeFrame: From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
Secondary outcomes:
measure: Event-free Survival (EFS)
timeFrame: Measured up to 2 years after the last participant is randomized
measure: Global Health Status/Quality of Life (GHS/QoL)
timeFrame: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit
measure: Percentage of Participants Achieving Composite Complete Remission (CR or CRi)
timeFrame: Up to 6 months after the first 225 participants are randomized
measure: Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)
timeFrame: Measured up to 2 years after the last participant is randomized
measure: Post Baseline Transfusion Independence Rate
timeFrame: Measured up to 2 years after the last participant is randomized
measure: Complete Remission (CR) Rate
timeFrame: Measured up to 2 years after the last participant is randomized
measure: Fatigue/Quality of Life (QoL)
timeFrame: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope /ID# 154105
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 154107
state: California
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center /ID# 162725
state: California
city: Atlanta
country: United States
facility: Emory Midtown Infectious Disease Clinic /ID# 162534
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 201133
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine /ID# 154108
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology /ID# 157190
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Res Ctr /ID# 155136
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 154992
state: Kentucky
city: Brewer
country: United States
facility: EMMC Cancer Care /ID# 154991
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 154104
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 200752
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 201155
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 167009
state: Massachusetts
city: Grand Rapids
country: United States
facility: Sepctrum Health Medical Center /ID# 159522
state: Michigan
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 154101
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077
state: New York
city: Durham
country: United States
facility: Duke Cancer Center /ID# 154106
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 154102
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 200854
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 154100
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center- Temple /ID# 157191
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 157192
state: Utah
city: Burlington
country: United States
facility: University Of Vermont Medical /ID# 157196
state: Vermont
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 154272
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 154271
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Health /ID# 154275
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 155094
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 155095
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital /ID# 163924
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 154274
state: Western Australia
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 167436
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888
state: Oberoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 154885
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 157882
state: Steiermark
city: Salzburg
country: Austria
facility: Duplicate_Landeskrankenhaus Salzburg /ID# 169719
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 155676
city: Jette
country: Belgium
facility: UZ Brussel /ID# 153393
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 153391
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 153392
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 154041
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 157779
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas /ID# 157778
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095
state: Sao Paulo
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre /ID# 159645
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital /ID# 159644
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 153650
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 153541
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 153651
state: Ontario
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital /ID# 167314
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 170148
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University /ID# 167316
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 167320
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital /ID# 167489
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 167490
state: Jilin
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 167492
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317
state: Zhejiang
city: Jinan
country: China
facility: Qilu Hospital of Shandong University /ID# 167485
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 153515
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 153383
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 153623
state: Osjecko-baranjska Zupanija
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno /ID# 154019
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 154021
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava /ID# 154017
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen /ID# 154018
city: Aalborg
country: Denmark
facility: Aalborg University Hospital /ID# 154047
state: Nordjylland
city: Tampere
country: Finland
facility: Tampere University Hospital /ID# 154963
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital /ID# 155223
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital /ID# 154964
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut Leveque /ID# 153789
state: Gironde
city: Angers
country: France
facility: Chu Angers /Id# 153792
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 153787
city: Toulouse Cedex 9
country: France
facility: IUCT Oncopole /ID# 153788
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 153054
state: Baden-Wuerttemberg
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 153060
state: Hessen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster /ID# 153059
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 153058
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 153055
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 153814
state: Hajdu-Bihar
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854
state: Nyiregyhaza
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813
state: Somogy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 153816
city: Budapest
country: Hungary
facility: Duplicate_Semmelweis Egyetem /ID# 153815
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 154173
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 154175
state: Tel-Aviv
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 158063
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 154174
city: Jerusalem
country: Israel
facility: Hadassah /ID# 154172
city: Petach Tikva
country: Israel
facility: Rabin Medical Center /ID# 154176
city: Lecce
country: Italy
facility: Presidio Ospedaliero Vito Fazzi /ID# 170837
state: Puglia
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata /ID# 152881
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino /ID# 158104
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 200824
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 167432
state: Fukui
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 201111
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 169095
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital /ID# 168316
state: Gunma
city: Higashi
country: Japan
facility: National Hospital Organization Mito Medical Center /ID# 168219
state: Ibaraki
city: Hitachi-shi
country: Japan
facility: Hitachi General Hospital /ID# 201109
state: Ibaraki
city: Kyoto-shi
country: Japan
facility: Duplicate_Kyoto Prefectural University of Medicine /ID# 167661
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 169259
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 168632
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 204124
state: Okayama
city: Osaka-sayama-shi
country: Japan
facility: Duplicate_Kindai University Hospital /ID# 167662
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 169055
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center /ID# 167814
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 168309
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639
state: Tokyo
city: Komae-shi
country: Japan
facility: The Jikei University Daisan Hospital /ID# 168745
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 167975
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 167634
state: Yamagata
city: Seoul
country: Korea, Republic of
facility: Duplicate_Konkuk University Medical Ctr /ID# 153973
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 153675
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 153674
city: Nordlenangen
country: Norway
facility: Akershus universitetssykehus /ID# 154279
state: Akershus
city: Drammen
country: Norway
facility: Drammen Sykehus /ID# 154280
state: Buskerud
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 154281
state: Hordaland
city: Gralum
country: Norway
facility: Sykehuset Ostfold Kalnes /ID# 157755
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846
state: Malopolskie
city: Chorzow
country: Poland
facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385
state: Slaskie
city: Braga
country: Portugal
facility: Duplicate_Hospital de Braga /ID# 154797
city: Porto
country: Portugal
facility: IPO Porto FG, EPE /ID# 154138
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System /ID# 160507
city: Kemerovo
country: Russian Federation
facility: Kuzbass Regional Clinical Hospital /ID# 157461
state: Kemerovskaya Oblast
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 155738
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268
state: Nizhegorodskaya Oblast
city: Penza
country: Russian Federation
facility: Duplicate_Regional Oncology Dispensary /ID# 153264
state: Penzenskaya Oblast
city: Ryazan
country: Russian Federation
facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460
state: Ryazanskaya Oblast
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267
state: Saratovskaya Oblast
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740
city: Samara
country: Russian Federation
facility: Samara State Medical University /ID# 157462
city: Pretoria
country: South Africa
facility: University of Pretoria /ID# 153682
state: Gauteng
city: Pretoria
country: South Africa
facility: Albert Alberts Stem Cell Transplant Centre /ID# 153684
state: Gauteng
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra /ID# 153254
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 153255
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 153193
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 153256
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 153260
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 153258
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 153257
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 153259
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset /ID# 153034
state: Uppsala Lan
city: Uddevalla
country: Sweden
facility: Uddevalla sjukhus /ID# 156875
state: Vastra Gotalands Lan
city: Lund
country: Sweden
facility: Dup_VO Hematologi /ID# 153174
city: Stockholm
country: Sweden
facility: Karolinska University Hospital /ID# 170003
city: Changhua city
country: Taiwan
facility: Changhua Christian Hospital /ID# 153899
state: Changhua County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902
city: Taichung City
country: Taiwan
facility: China Medical University Hospital /ID# 153904
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 153900
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 202073
city: Ankara
country: Turkey
facility: Ankara Universitesi Fakultesi /ID# 155200
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip /ID# 155201
city: Kiev
country: Ukraine
facility: Kyiv city clinical hospital #9 /ID# 153510
state: Vinnytska Oblast
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511
city: Kyiv
country: Ukraine
facility: Kyiv Regional Onco Dispensary /ID# 153514
city: Poltava
country: Ukraine
facility: Poltava Reg Clin Hosp Sklifoso /ID# 153513
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
citation: Pratz KW, Chai X, Xie J, Yin L, Nie X, Montez M, Iantuono E, Downs L, Ma E. Cost-Effectiveness Analysis of Venetoclax in Combination with Azacitidine Versus Azacitidine Monotherapy in Patients with Acute Myeloid Leukemia Who are Ineligible for Intensive Chemotherapy: From a US Third Party Payer Perspective. Pharmacoeconomics. 2022 Aug;40(8):777-790. doi: 10.1007/s40273-022-01145-7. Epub 2022 Jun 13.
citation: Konopleva M, Thirman MJ, Pratz KW, Garcia JS, Recher C, Pullarkat V, Kantarjian HM, DiNardo CD, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Wei AH. Impact of FLT3 Mutation on Outcomes after Venetoclax and Azacitidine for Patients with Treatment-Naive Acute Myeloid Leukemia. Clin Cancer Res. 2022 Jul 1;28(13):2744-2752. doi: 10.1158/1078-0432.CCR-21-3405.
citation: Pollyea DA, DiNardo CD, Arellano ML, Pigneux A, Fiedler W, Konopleva M, Rizzieri DA, Smith BD, Shinagawa A, Lemoli RM, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Kantarjian HM. Impact of Venetoclax and Azacitidine in Treatment-Naive Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. Clin Cancer Res. 2022 Jul 1;28(13):2753-2761. doi: 10.1158/1078-0432.CCR-21-3467.
citation: Pratz KW, Jonas BA, Pullarkat V, Recher C, Schuh AC, Thirman MJ, Garcia JS, DiNardo CD, Vorobyev V, Fracchiolla NS, Yeh SP, Jang JH, Ozcan M, Yamamoto K, Illes A, Zhou Y, Dail M, Chyla B, Potluri J, Dohner H. Measurable Residual Disease Response and Prognosis in Treatment-Naive Acute Myeloid Leukemia With Venetoclax and Azacitidine. J Clin Oncol. 2022 Mar 10;40(8):855-865. doi: 10.1200/JCO.21.01546. Epub 2021 Dec 15.
citation: DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.