Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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 ID: NCT03069352
Conditions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffit Cancer Center /ID# 164273, Tampa, Florida, United States
Norton Cancer Institute /ID# 158998, Louisville, Kentucky, United States
Univ of Pittsburgh Med Ctr /ID# 158997, Pittsburgh, Pennsylvania, United States
Univ TX, MD Anderson /ID# 159678, Houston, Texas, United States
Swedish Medical Center /ID# 161280, Seattle, Washington, United States
Gundersen Health System /ID# 164272, La Crosse, Wisconsin, United States
Cemic /Id# 159676, Buenos Aires, , Argentina
Sanatorio Allende /ID# 159675, Cordoba, , Argentina
Calvary Mater Newcastle /ID# 160123, Waratah, New South Wales, Australia
Westmead Hospital /ID# 160121, Westmead, New South Wales, Australia
Alfred Hospital /ID# 160125, Melbourne, Victoria, Australia
Box Hill Hospital /ID# 162920, Melbourne, Victoria, Australia
Universitair Ziekenhuis Antwerpen /ID# 159566, Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint Luc /ID# 159567, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Centro de Pesquisas Oncologicas /ID# 163567, Florianopolis, Santa Catarina, Brazil
Hospital de Cancer de Barretos /ID# 163568, Barretos, Sao Paulo, Brazil
Hospital do Cancer Mae de Deus /ID# 163416, Porto Alegre, , Brazil
Casa de Saúde Santa Marcelina /ID# 163413, Sao Paulo, , Brazil
University of Alberta Hospital /ID# 159646, Edmonton, Alberta, Canada
CISSS de la Monteregie /ID# 159782, Greenfield Park, Quebec, Canada
Hospital Maisonneuve-Rosemont /ID# 159780, Montreal, Quebec, Canada
Hopital Sacre Coeur Montreal /ID# 160982, Montreal, Quebec, Canada
Fujian Medical Univ Union Hosp /ID# 167321, Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University /ID# 170147, Guangzhou, Guangdong, China
Jiangsu Province People's Hospital /ID# 167511, Nanjing, Jiangsu, China
The First Hosp of Jilin Univ /ID# 167512, Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong /ID# 167325, Shanghai, Shanghai, China
West China Hospital /ID# 167514, Chengdu, Sichuan, China
Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509, Tianjin, Tianjin, China
The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324, Hangzhou, Zhejiang, China
Qilu Hospital of Shandong Univ /ID# 167507, Jinan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515, Wuhan, , China
Henan Cancer Hospital /ID# 167327, Zhengzhou, Henan, , China
Fakultni Nemocnice Brno /ID# 159247, Brno, , Czechia
Univ Hosp Ostrava-Poruba /ID# 159246, Ostrava, , Czechia
Fakult Nem Kralovske Vinohrady /ID# 159248, Prague, , Czechia
Centre Hospitalier Lyon Sud /ID# 159705, Pierre Benite CEDEX, Rhone, France
Centre Hospitalier Le Mans /ID# 159702, Le Mans CEDEX 9, Sarthe, France
Centre Hospitalier de la Cote /ID# 159697, Bayonne, , France
CHU Bordeaux /ID# 159704, Pessac, , France
CHU De Nancy /ID# 159700, Vandoeuvre Les Nancy Cedex, , France
Schwarzwald-Baar-Klinikum /ID# 159571, Villingen-Schwenningen, Baden-Wuerttemberg, Germany
Vivantes Klinikum Am Urban /ID# 159569, Berlin, , Germany
Universitaetsklinikum Hamburg /ID# 161760, Hamburg, , Germany
General Hospital of Athens Laiko /ID# 157870, Athens, Attiki, Greece
Gen Univ Hosp Alexandroupolis /ID# 157868, Alexandroupolis, , Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869, Athens, , Greece
University Gen Hosp of Patra /ID# 157871, Patras, , Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 157867, Thessaloniki, , Greece
Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127, Budapest IX, Budapest, Hungary
Pecsi Tudomanyegyetem /ID# 163161, Pécs, Pecs, Hungary
Semmelweis Egyetem I. Belklini /ID# 158180, Budapest, , Hungary
Debreceni Egyetem Klinikai Koz /ID# 158178, Debrecen, , Hungary
Petz Aladar Megyei Oktato Korh /ID# 161739, Gyor, , Hungary
Kaposi Mor Oktato Korhaz /ID# 158175, Kaposvar, , Hungary
Bacs-Kiskun Megyei Korhaz /ID# 160973, Kecskemét, , Hungary
St. James's Hospital /ID# 162730, Dublin 8, Dublin, Ireland
Beaumont Hospital /ID# 162733, Dublin, , Ireland
University Hospital Galway /ID# 162734, Galway, , Ireland
University Hospital Limerick /ID# 162735, Limerick, , Ireland
University of Fukui Hospital /ID# 159770, Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 159688, Fukuoka-shi, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 160597, Maebashi-shi, Gunma, Japan
National Hospital Organization Mito Medical Center /ID# 162988, Higashi Ibaraki-gun, Ibaraki, Japan
Kyoto Prefect Univ Med /ID# 160101, Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 161151, Sendai-shi, Miyagi, Japan
Nagasaki University Hospital /ID# 160233, Nagasaki-shi, Nagasaki, Japan
Osaka City University Hospital /ID# 159722, Osaka-shi, Osaka, Japan
Kinki University -Osakasayama Campus /ID# 160777, Osakasayama-shi, Osaka, Japan
Tokyo Metropolitan Komagome Hospital /ID# 160759, Bunkyo-ku, Tokyo, Japan
Tokyo Jikei Daisan Hospital /ID# 159769, Komae-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 160678, Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 161223, Yamagata-shi, Yamagata, Japan
Akita University Hospital /ID# 160602, Akita, , Japan
Saitama Med Univ Int Med Ctr /ID# 161308, Hidaka, , Japan
NHO Nagoya Medical Center /ID# 159768, Nagoya, , Japan
Dokkyo Medical University Hosp /ID# 159650, Shimotsuga, , Japan
Juntendo University Hospital /ID# 159781, Tokyo, , Japan
Pusan National University Hosp /ID# 158725, Busan, Busan Gwang Yeogsi, Korea, Republic of
Chungnam National University Hospital /ID# 158726, Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of
Cath Univ Seoul St Mary's Hosp /ID# 158724, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 162253, Seoul, , Korea, Republic of
Instituto Nacional de Cancerol /ID# 159269, Ciudad de México, Ciudad De Mexico, Mexico
Centro de Invest Clin Chapulte /ID# 162625, Morelia, Michoacan, Mexico
Hosp. Univ. Dr. Jose E. Gonz /ID# 159268, Monterrey, Nuevo Leon, Mexico
North Shore Hospital /ID# 160132, Auckland, , New Zealand
Middlemore Clinical Trials /ID# 160131, Auckland, , New Zealand
Haukeland University Hospital /ID# 165630, Bergen, Hordaland, Norway
Sykehuset Ostfold Kalnes /ID# 165632, Gralum, , Norway
VA Caribbean Healthcare System /ID# 158999, San Juan, , Puerto Rico
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991, Kemerovo, Kemerovskaya Oblast, Russian Federation
Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186, Nizhnij Novgorod, Nizhegorodskaya Oblast, Russian Federation
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126, Ryazan, Ryazanskaya Oblast, Russian Federation
City Clinical Hospital Botkina /ID# 164086, Moscow, , Russian Federation
Samara State Medical Universit /ID# 164173, Samara, , Russian Federation
Almazov North-West Federal Med /ID# 162170, Sankt-peterburg, , Russian Federation
saratov state medical /ID# 163130, Saratov, , Russian Federation
Saint Petersburg State Institu /ID# 162171, St. Petersburg, , Russian Federation
Yaroslavl Regional Clinic Hosp /ID# 162172, Yaroslavl, , Russian Federation
Netcare Pretoria East Hospital /ID# 157373, Pretoria, Gauteng, South Africa
Tshwane District Hospital /ID# 157361, Pretoria, Gauteng, South Africa
Hospital Universitario y Politecnico La Fe /ID# 161181, Valencia, Valenciana, Spain
Hospital Infanta Leonor /ID# 161180, Madrid, , Spain
National Taiwan Univ Hosp /ID# 162781, Taipei City, Taipei, Taiwan
Tri-Service General Hospital /ID# 161683, Taipei City, Taipei, Taiwan
Kaohsiung Medical University /ID# 161693, Kaohsiung, , Taiwan
Heartlands Hospital /ID# 163534, Birmingham, , United Kingdom
University Hospital of Wales /ID# 162726, Cardiff, , United Kingdom
Northwick Park Hospital /ID# 162727, Harrow, , United Kingdom
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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