Clinical trial NCT03069352: A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
Official title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia
Leukemia
Treatment naïve
Venetoclax
Cytarabine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 211
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: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

Detailed description: Acute myeloid leukemia (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 patient has, and the age of the patient 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 cytarabine works better than cytarabine on its own.

This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors), placebo-controlled, multicenter study in patients with AML who are 18 or more years old and have not been treated before. Patients who take part in this study should not be suitable for intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study which will take place at approximately 125 hospitals globally. In this study, 2/3 of patients will receive venetoclax every day with cytarabine and the remaining 1/3 will receive placebo (dummy) tablets with cytarabine.

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.

Eligibility criteria: Inclusion Criteria:

1. Participant must have histological confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be:

   * ≥ 75 years of age OR
   * ≥ 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:

     * Eastern Cooperative Oncology Group (ECOG) performance status of 2 - 3
     * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina
     * Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%
     * Creatinine clearance ≥ 30 mL/min to \< 45 ml/min
     * Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN)
     * Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment
2. Participant must have an ECOG performance status:

   * of 0 to 2 for subjects ≥ 75 years of age OR
   * of 0 to 3 for subjects between 18 to 74 years of age
3. Participant must have a projected life expectancy of at least 12 weeks.
4. Participant must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
5. Participant must have adequate liver function as demonstrated by:

   * aspartate aminotransferase (AST) ≤ 3.0 × ULN\*
   * alanine aminotransferase (ALT) ≤ 3.0 × ULN\*
   * bilirubin ≤ 1.5 × ULN\*

     * Subjects who are \< 75 years of age may have bilirubin of ≤ 3.0 × ULN

   (\*Unless considered to be due to leukemic organ involvement.)
6. Female participants must be either postmenopausal defined as:

   * Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
   * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level \> 40 IU/L.

   OR
   * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

   OR
   * A woman of childbearing potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
7. Male participants who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
8. Females of childbearing potential must have negative results for pregnancy test performed:

   * At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
   * 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.
   * Subjects with borderline pregnancy tests at Screening must have a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.
9. Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

1. Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for myelodysplastic syndrome is allowed except for use of cytarabine.
2. Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation.
3. Participants that have acute promyelocytic leukemia (APL).
4. Participant has known central nervous system (CNS) involvement with AML.
5. 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, if required per local guidelines or institutional standards.
6. Participant is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
7. Participant has received strong or moderate cytochrome P450 3A4 (CYP3A) inducers 7 days prior to the initiation of study treatment.

   * Chinese subjects are excluded from receiving strong and/or moderate CYP3A inhibitors 7 days prior to the initiation of study treatment through the end of intensive pharmacokinetic (PK) collection (24 hours post dose on Cycle 1 Day 10).
8. Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the initiation of study treatment.
9. Participant has cardiovascular disability status of New York Heart Association Class \> 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain. Class 3 is defined as cardiac disease which subjects are comfortable at rest but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4 is defined as cardiac disease which subjects have an inability to carry on any physical activity without discomfort, symptoms of heart failure at rest, and if any physical activity is undertaken then discomfort increases.
10. 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 LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
11. Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
12. Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
13. Participant has a history of other malignancies prior to study entry, with the exception of:

    * 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.
14. Participant has a white blood cell count \> 25 × 10\^9/L. (Note: hydroxyurea administration or leukapheresis is permitted to meet this criterion).
15. Previous treatment with venetoclax and/or current participation in any other research study with investigational products.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
Secondary outcomes:
measure: Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2
timeFrame: Cycle 1, 28 days
measure: Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2
timeFrame: Cycle 1, 28 days
measure: Percentage of Participants With Complete Remission
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, and 9
measure: Change From Baseline in Global Health Status / Quality of Life
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, and 9
measure: Event-free Survival (EFS)
timeFrame: From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
measure: Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence
timeFrame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
measure: Percentage of Participants With Post Baseline Platelet Transfusion Independence
timeFrame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
measure: Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
timeFrame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
measure: Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
timeFrame: From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
measure: Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Overall Survival (OS) by Mutation Subgroups
timeFrame: From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
measure: Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
measure: Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup
timeFrame: Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffit Cancer Center /ID# 164273
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 158998
state: Kentucky
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Med Ctr /ID# 158997
state: Pennsylvania
city: Houston
country: United States
facility: Univ TX, MD Anderson /ID# 159678
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center /ID# 161280
state: Washington
city: La Crosse
country: United States
facility: Gundersen Health System /ID# 164272
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Cemic /Id# 159676
city: Cordoba
country: Argentina
facility: Sanatorio Allende /ID# 159675
city: Waratah
country: Australia
facility: Calvary Mater Newcastle /ID# 160123
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 160121
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital /ID# 160125
state: Victoria
city: Melbourne
country: Australia
facility: Box Hill Hospital /ID# 162920
state: Victoria
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 159566
state: Antwerpen
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 159567
state: Bruxelles-Capitale
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas /ID# 163567
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos /ID# 163568
state: Sao Paulo
city: Porto Alegre
country: Brazil
facility: Hospital do Cancer Mae de Deus /ID# 163416
city: Sao Paulo
country: Brazil
facility: Casa de Saúde Santa Marcelina /ID# 163413
city: Edmonton
country: Canada
facility: University of Alberta Hospital /ID# 159646
state: Alberta
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 159782
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont /ID# 159780
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre Coeur Montreal /ID# 160982
state: Quebec
city: Fuzhou
country: China
facility: Fujian Medical Univ Union Hosp /ID# 167321
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 170147
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Province People's Hospital /ID# 167511
state: Jiangsu
city: Changchun
country: China
facility: The First Hosp of Jilin Univ /ID# 167512
state: Jilin
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong /ID# 167325
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital /ID# 167514
state: Sichuan
city: Tianjin
country: China
facility: Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324
state: Zhejiang
city: Jinan
country: China
facility: Qilu Hospital of Shandong Univ /ID# 167507
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515
city: Zhengzhou, Henan
country: China
facility: Henan Cancer Hospital /ID# 167327
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno /ID# 159247
city: Ostrava
country: Czechia
facility: Univ Hosp Ostrava-Poruba /ID# 159246
city: Prague
country: Czechia
facility: Fakult Nem Kralovske Vinohrady /ID# 159248
city: Pierre Benite CEDEX
country: France
facility: Centre Hospitalier Lyon Sud /ID# 159705
state: Rhone
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier Le Mans /ID# 159702
state: Sarthe
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote /ID# 159697
city: Pessac
country: France
facility: CHU Bordeaux /ID# 159704
city: Vandoeuvre Les Nancy Cedex
country: France
facility: CHU De Nancy /ID# 159700
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum /ID# 159571
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban /ID# 159569
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg /ID# 161760
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 157870
state: Attiki
city: Alexandroupolis
country: Greece
facility: Gen Univ Hosp Alexandroupolis /ID# 157868
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869
city: Patras
country: Greece
facility: University Gen Hosp of Patra /ID# 157871
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 157867
city: Budapest IX
country: Hungary
facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127
state: Budapest
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem /ID# 163161
state: Pecs
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. Belklini /ID# 158180
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Koz /ID# 158178
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korh /ID# 161739
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz /ID# 158175
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz /ID# 160973
city: Dublin 8
country: Ireland
facility: St. James's Hospital /ID# 162730
state: Dublin
city: Dublin
country: Ireland
facility: Beaumont Hospital /ID# 162733
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 162734
city: Limerick
country: Ireland
facility: University Hospital Limerick /ID# 162735
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 159770
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 159688
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital /ID# 160597
state: Gunma
city: Higashi Ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center /ID# 162988
state: Ibaraki
city: Kyoto-shi
country: Japan
facility: Kyoto Prefect Univ Med /ID# 160101
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 161151
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 160233
state: Nagasaki
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital /ID# 159722
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kinki University -Osakasayama Campus /ID# 160777
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital /ID# 160759
state: Tokyo
city: Komae-shi
country: Japan
facility: Tokyo Jikei Daisan Hospital /ID# 159769
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 160678
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 161223
state: Yamagata
city: Akita
country: Japan
facility: Akita University Hospital /ID# 160602
city: Hidaka
country: Japan
facility: Saitama Med Univ Int Med Ctr /ID# 161308
city: Nagoya
country: Japan
facility: NHO Nagoya Medical Center /ID# 159768
city: Shimotsuga
country: Japan
facility: Dokkyo Medical University Hosp /ID# 159650
city: Tokyo
country: Japan
facility: Juntendo University Hospital /ID# 159781
city: Busan
country: Korea, Republic of
facility: Pusan National University Hosp /ID# 158725
state: Busan Gwang Yeogsi
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 158726
state: Daejeon Gwang Yeogsi
city: Seoul
country: Korea, Republic of
facility: Cath Univ Seoul St Mary's Hosp /ID# 158724
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 162253
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Cancerol /ID# 159269
state: Ciudad De Mexico
city: Morelia
country: Mexico
facility: Centro de Invest Clin Chapulte /ID# 162625
state: Michoacan
city: Monterrey
country: Mexico
facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 159268
state: Nuevo Leon
city: Auckland
country: New Zealand
facility: North Shore Hospital /ID# 160132
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials /ID# 160131
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 165630
state: Hordaland
city: Gralum
country: Norway
facility: Sykehuset Ostfold Kalnes /ID# 165632
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System /ID# 158999
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991
state: Kemerovskaya Oblast
city: Nizhnij Novgorod
country: Russian Federation
facility: Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186
state: Nizhegorodskaya Oblast
city: Ryazan
country: Russian Federation
facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126
state: Ryazanskaya Oblast
city: Moscow
country: Russian Federation
facility: City Clinical Hospital Botkina /ID# 164086
city: Samara
country: Russian Federation
facility: Samara State Medical Universit /ID# 164173
city: Sankt-peterburg
country: Russian Federation
facility: Almazov North-West Federal Med /ID# 162170
city: Saratov
country: Russian Federation
facility: saratov state medical /ID# 163130
city: St. Petersburg
country: Russian Federation
facility: Saint Petersburg State Institu /ID# 162171
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinic Hosp /ID# 162172
city: Pretoria
country: South Africa
facility: Netcare Pretoria East Hospital /ID# 157373
state: Gauteng
city: Pretoria
country: South Africa
facility: Tshwane District Hospital /ID# 157361
state: Gauteng
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 161181
state: Valenciana
city: Madrid
country: Spain
facility: Hospital Infanta Leonor /ID# 161180
city: Taipei City
country: Taiwan
facility: National Taiwan Univ Hosp /ID# 162781
state: Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 161683
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University /ID# 161693
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital /ID# 163534
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales /ID# 162726
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital /ID# 162727
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856.
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: Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8.