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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02993523
Other study ID # M15-656
Secondary ID 2016-001466-28
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 2, 2017
Est. completion date September 25, 2024

Study information

Verified date June 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 443
Est. completion date September 25, 2024
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Intervention

Drug:
Azacitidine
Solution for subcutaneous or intravenous administration.
Venetoclax
Tablet
Placebo
Matching placebo tablet

Locations

Country Name City State
Australia Royal Adelaide Hospital /ID# 154271 Adelaide South Australia
Australia Alfred Health /ID# 154275 Melbourne Victoria
Australia St Vincent's Hospital Melbourne /ID# 155094 Melbourne Victoria
Australia Sir Charles Gairdner Hospital /ID# 163924 Nedlands Western Australia
Australia The Royal Melbourne Hospital /ID# 155095 Parkville Victoria
Australia Royal Perth Hospital /ID# 154274 Perth Western Australia
Australia Princess Alexandra Hospital /ID# 154272 Woolloongabba Queensland
Austria Medizinische Universitaet Graz /ID# 157882 Graz Steiermark
Austria Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888 Linz Oberoesterreich
Austria Ordensklinikum Linz GmbH Elisabethinen /ID# 154885 Linz Oberoesterreich
Austria Duplicate_Landeskrankenhaus Salzburg /ID# 169719 Salzburg
Austria Universitaetsklinikum St. Poelten /ID# 167436 Sankt Poelten Niederoesterreich
Austria Hanusch Krankenhaus /ID# 155676 Wien
Belgium AZ Sint-Jan Brugge /ID# 154041 Brugge
Belgium UZ Gent /ID# 153392 Gent Oost-Vlaanderen
Belgium UZ Brussel /ID# 153393 Jette Bruxelles-Capitale
Belgium UCL Saint-Luc /ID# 153391 Woluwe-Saint-Lambert Bruxelles-Capitale
Brazil Hospital de Clinicas de Porto Alegre /ID# 157779 Porto Alegre Rio Grande Do Sul
Brazil Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099 Ribeirão Preto Sao Paulo
Brazil Instituto de Ensino e Pesquisa São Lucas /ID# 157778 São Paulo Sao Paulo
Brazil Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095 São Paulo Sao Paulo
Canada Tom Baker Cancer Centre /ID# 159645 Calgary Alberta
Canada Juravinski Cancer Centre /ID# 153650 Hamilton Ontario
Canada Ottawa Hospital Research Institute /ID# 153541 Ottawa Ontario
Canada Princess Margaret Cancer Centre /ID# 153651 Toronto Ontario
Canada St. Paul's Hospital /ID# 159644 Vancouver British Columbia
China The First Hospital of Jilin University /ID# 167490 Changchun Jilin
China West China Hospital, Sichuan University /ID# 167492 Chengdu Sichuan
China Fujian Medical University Union Hospital /ID# 167314 Fuzhou Fujian
China Nanfang Hospital of Southern Medical University /ID# 170148 Guangzhou Guangdong
China The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317 Hangzhou Zhejiang
China Qilu Hospital of Shandong University /ID# 167485 Jinan
China Jiangsu Province Hospital /ID# 167489 Nanjing Jiangsu
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318 Shanghai Shanghai
China The Second Hospital of Hebei Medical University /ID# 167316 Shijiazhuang Hebei
China Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487 Tianjin Tianjin
China Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315 Wuhan Hubei
China Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493 Wuhan Hubei
China Henan Cancer Hospital /ID# 167320 Zhengzhou Henan
Croatia Duplicate_Klinicki bolnicki centar Osijek /ID# 153623 Osijek Osjecko-baranjska Zupanija
Croatia Clinical Hospital Dubrava /ID# 153515 Zagreb Grad Zagreb
Croatia Klinicki bolnicki centar Zagreb /ID# 153383 Zagreb Grad Zagreb
Czechia Fakultni Nemocnice Brno /ID# 154019 Brno
Czechia Fakultni nemocnice Hradec Kralove /ID# 154021 Hradec Kralove
Czechia Fakultni nemocnice Ostrava /ID# 154017 Ostrava
Czechia Fakultni nemocnice Plzen /ID# 154018 Plzen
Denmark Aalborg University Hospital /ID# 154047 Aalborg Nordjylland
Finland Helsinki University Hospital /ID# 155223 Helsinki Uusimaa
Finland Tampere University Hospital /ID# 154963 Tampere Pirkanmaa
Finland Turku University Hospital /ID# 154964 Turku
France Chu Angers /Id# 153792 Angers
France AP-HP - Hopital Saint-Louis /ID# 153787 Paris
France CHU Bordeaux - Hopital Haut Leveque /ID# 153789 Pessac Gironde
France IUCT Oncopole /ID# 153788 Toulouse Cedex 9
Germany Universitaetsklinikum Frankfurt /ID# 153060 Frankfurt am Main Hessen
Germany Universitaetsklinikum Halle (Saale) /ID# 153058 Halle (Saale)
Germany Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056 Hamburg
Germany Medizinische Hochschule Hannover /ID# 153055 Hannover
Germany Universitaetsklinikum Muenster /ID# 153059 Muenster Nordrhein-Westfalen
Germany Universitaetsklinikum Ulm /ID# 153054 Ulm Baden-Wuerttemberg
Hungary Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990 Budapest
Hungary Duplicate_Semmelweis Egyetem /ID# 153815 Budapest
Hungary Semmelweis Egyetem /ID# 153816 Budapest
Hungary Debreceni Egyetem Klinikai Kozpont /ID# 153814 Debrecen Hajdu-Bihar
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813 Kaposvár Somogy
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854 Nyíregyháza Nyiregyhaza
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812 Szeged Csongrad
Israel Assaf Harofeh Medical Center /ID# 158063 Be'er Ya'aqov
Israel Rambam Health Care Campus /ID# 154174 Haifa
Israel Hadassah /ID# 154172 Jerusalem
Israel Rabin Medical Center /ID# 154176 Petach Tikva
Israel The Chaim Sheba Medical Center /ID# 154173 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 154175 Tel Aviv-Yafo Tel-Aviv
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220 Ancona
Italy Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875 Bergamo
Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883 Bologna
Italy Ospedale Policlinico San Martino /ID# 158104 Genova
Italy Presidio Ospedaliero Vito Fazzi /ID# 170837 Lecce Puglia
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882 Milan
Italy Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879 Napoli
Italy Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877 Reggio Calabria
Italy Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876 Rome
Italy Fondazione PTV Policlinico Tor Vergata /ID# 152881 Rome Roma
Japan Juntendo University Hospital /ID# 168309 Bunkyo-ku Tokyo
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639 Bunkyo-ku Tokyo
Japan Kyushu University Hospital /ID# 169095 Fukuoka-shi Fukuoka
Japan National Hospital Organization Kyushu Cancer Center /ID# 201111 Fukuoka-shi Fukuoka
Japan Saitama Medical University International Medical Center /ID# 167814 Hidaka-shi Saitama
Japan National Hospital Organization Mito Medical Center /ID# 168219 Higashi Ibaraki
Japan Hitachi General Hospital /ID# 201109 Hitachi-shi Ibaraki
Japan The Jikei University Daisan Hospital /ID# 168745 Komae-shi Tokyo
Japan Duplicate_Kyoto Prefectural University of Medicine /ID# 167661 Kyoto-shi Kyoto
Japan Gunmaken Saiseikai Maebashi Hospital /ID# 168316 Maebashi-shi Gunma
Japan Nagasaki University Hospital /ID# 168632 Nagasaki-shi Nagasaki
Japan Aichi Cancer Center Hospital /ID# 200824 Nagoya-shi Aichi
Japan Okayama University Hospital /ID# 204124 Okayama-shi Okayama
Japan Duplicate_Kindai University Hospital /ID# 167662 Osaka-sayama-shi Osaka
Japan Osaka Metropolitan University Hospital /ID# 169055 Osaka-shi Osaka
Japan Tohoku University Hospital /ID# 169259 Sendai-shi Miyagi
Japan NTT Medical Center Tokyo /ID# 167975 Shinagawa-ku Tokyo
Japan Yamagata University Hospital /ID# 167634 Yamagata-shi Yamagata
Japan University of Fukui Hospital /ID# 167432 Yoshida-gun Fukui
Korea, Republic of Duplicate_Konkuk University Medical Ctr /ID# 153973 Seoul Seoul Teugbyeolsi
Korea, Republic of Samsung Medical Center /ID# 153674 Seoul
Korea, Republic of Seoul National University Hospital /ID# 153675 Seoul
Norway Haukeland University Hospital /ID# 154281 Bergen Hordaland
Norway Drammen Sykehus /ID# 154280 Drammen Buskerud
Norway Sykehuset Ostfold Kalnes /ID# 157755 Gralum
Norway Akershus universitetssykehus /ID# 154279 Nordlenangen Akershus
Poland SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385 Chorzow Slaskie
Poland Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846 Krakow Malopolskie
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu /ID# 153389 Wroclaw Dolnoslaskie
Portugal Duplicate_Hospital de Braga /ID# 154797 Braga
Portugal IPO Porto FG, EPE /ID# 154138 Porto
Puerto Rico VA Caribbean Healthcare System /ID# 160507 San Juan
Russian Federation Kuzbass Regional Clinical Hospital /ID# 157461 Kemerovo Kemerovskaya Oblast
Russian Federation Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740 Moscow
Russian Federation Moscow State budget healthcare /ID# 155738 Moscow Moskva
Russian Federation Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268 Nizhniy Novgorod Nizhegorodskaya Oblast
Russian Federation Duplicate_Regional Oncology Dispensary /ID# 153264 Penza Penzenskaya Oblast
Russian Federation State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460 Ryazan Ryazanskaya Oblast
Russian Federation Samara State Medical University /ID# 157462 Samara
Russian Federation Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267 Saratov Saratovskaya Oblast
South Africa Albert Alberts Stem Cell Transplant Centre /ID# 153684 Pretoria Gauteng
South Africa University of Pretoria /ID# 153682 Pretoria Gauteng
Spain Hospital Clinic de Barcelona /ID# 153255 Barcelona
Spain Hospital Santa Creu i Sant Pau /ID# 153193 Barcelona
Spain Hospital General Universitario Gregorio Maranon /ID# 153260 Madrid
Spain Hospital Universitario 12 de Octubre /ID# 153258 Madrid
Spain Hospital Universitario de la Princesa /ID# 153256 Madrid
Spain Hospital Universitario Virgen de la Victoria /ID# 153257 Malaga
Spain Hospital Universitario de Navarra /ID# 153254 Pamplona Navarra
Spain Hospital Universitario y Politecnico La Fe /ID# 153259 Valencia
Sweden Dup_VO Hematologi /ID# 153174 Lund
Sweden Karolinska University Hospital /ID# 170003 Stockholm
Sweden Uddevalla sjukhus /ID# 156875 Uddevalla Vastra Gotalands Lan
Sweden Akademiska Sjukhuset /ID# 153034 Uppsala Uppsala Lan
Taiwan Changhua Christian Hospital /ID# 153899 Changhua city Changhua County
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902 Kaohsiung
Taiwan China Medical University Hospital /ID# 153904 Taichung City
Taiwan National Taiwan University Hospital /ID# 153900 Taipei City
Turkey Ankara Universitesi Fakultesi /ID# 155200 Ankara
Turkey Hacettepe University Faculty of Medicine /ID# 202073 Ankara
Turkey Ondokuz Mayis Universitesi Tip /ID# 155201 Samsun
Ukraine Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511 Dnipro
Ukraine Kyiv city clinical hospital #9 /ID# 153510 Kiev Vinnytska Oblast
Ukraine Kyiv Regional Onco Dispensary /ID# 153514 Kyiv
Ukraine Poltava Reg Clin Hosp Sklifoso /ID# 153513 Poltava
United States Emory Midtown Infectious Disease Clinic /ID# 162534 Atlanta Georgia
United States Johns Hopkins University /ID# 154104 Baltimore Maryland
United States Beth Israel Deaconess Medical Center /ID# 201155 Boston Massachusetts
United States Dana-Farber Cancer Institute /ID# 167009 Boston Massachusetts
United States Massachusetts General Hospital /ID# 200752 Boston Massachusetts
United States EMMC Cancer Care /ID# 154991 Brewer Maine
United States University Of Vermont Medical /ID# 157196 Burlington Vermont
United States Northwestern University Feinberg School of Medicine /ID# 201133 Chicago Illinois
United States University of Chicago Medicine /ID# 154108 Chicago Illinois
United States City of Hope /ID# 154105 Duarte California
United States Duke Cancer Center /ID# 154106 Durham North Carolina
United States Fort Wayne Medical Oncology /ID# 157190 Fort Wayne Indiana
United States Sepctrum Health Medical Center /ID# 159522 Grand Rapids Michigan
United States University of Texas MD Anderson Cancer Center /ID# 154100 Houston Texas
United States University of California, Los Angeles /ID# 154107 Los Angeles California
United States Norton Cancer Institute /ID# 154992 Louisville Kentucky
United States Tennessee Oncology-Nashville Centennial /ID# 200854 Nashville Tennessee
United States Columbia Univ Medical Center /ID# 154101 New York New York
United States Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077 New York New York
United States University of Pittsburgh MC /ID# 154102 Pittsburgh Pennsylvania
United States University of California, Davis Comprehensive Cancer Center /ID# 162725 Sacramento California
United States University of Utah /ID# 157192 Salt Lake City Utah
United States Baylor Scott & White Medical Center- Temple /ID# 157191 Temple Texas
United States Cotton-O'Neil Clinical Res Ctr /ID# 155136 Topeka Kansas

Sponsors (2)

Lead Sponsor Collaborator
AbbVie Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio. 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)
Primary Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count >10^3/ microliter (mcL), platelets >10^5/mcL, red cell transfusion independence, and bone marrow with <5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of =10^3/mcL or platelets =10^5/mcL. Percentages are rounded off to whole number at the nearest decimal. From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
Secondary Event-free Survival (EFS) EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause. Measured up to 2 years after the last participant is randomized
Secondary Global Health Status/Quality of Life (GHS/QoL) Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30). 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
Secondary Percentage of Participants Achieving Composite Complete Remission (CR or CRi) This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count > 10^3/mcL, platelets > 10^5/mcL, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of <= 10^3/mcL or platelets <= 10^5/mcL. Up to 6 months after the first 225 participants are randomized
Secondary Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh) A response of CRh is defined as Bone marrow with <5% blasts, peripheral blood neutrophil count >0.5*10^3/mcL and peripheral blood platelet count >0.5*10^5/mcL. Measured up to 2 years after the last participant is randomized
Secondary Post Baseline Transfusion Independence Rate Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence. Measured up to 2 years after the last participant is randomized
Secondary Complete Remission (CR) Rate The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML. Measured up to 2 years after the last participant is randomized
Secondary Fatigue/Quality of Life (QoL) Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score 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
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