Spots Global Cancer Trial Database for Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study
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Trial Identification
Brief Title: Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study
Official Title: Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study
Study ID: NCT00715637
Study Description
Brief Summary: Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Medical Center, Los Angelas, California, United States
Univ of Southern California Comprehensive Cancer Center, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
University of Colorado Health Sciences Center, Aurora, Colorado, United States
Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
The Blood and Marrow Transplant Group of GA, Atlanta, Georgia, United States
Northwestern University School of Medicine, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Iowa Hospitals, Iowa City, Iowa, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Michigan State University, Lansing, Michigan, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northshore Hospital - Monter Cancer Center, Lake Success, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Taussig Cancer Center, Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Cancer Center of the Carolinas, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Intermountain Healthcare, Salt Lake City, Utah, United States
Hospital Italiano de La Plata, Buenos Aires, , Argentina
Hospital General de Agudos "Dr. Teodoro Alvarez", Ciudad Autónoma de Bs. As., , Argentina
Clinical Hematology Service, Ciudad Autónoma de Bs. As., , Argentina
Hospital Provincial de Cordoba, Cordoba, , Argentina
Sanatorio Parque, Rosario - Santa Fe, , Argentina
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
LKH-Universitats Klinikum Graz, Graz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Landesklinikum St. Polten, St. Polten, , Austria
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
University Hospital Gent, Gent, , Belgium
UCL de Mont-Godinne, Yvoir, , Belgium
London Health Sciences Centre, London, Ontario, Canada
QEII Center for Clinical Research, Halifax, , Canada
The Ottawa Hospital - General Campus, Ottawa, , Canada
Hospital Santa Maria, Santiago, , Chile
Hospital DIPRECA, Santiago, , Chile
Hospital Dr. Gustavo Fricke, Viña del Mar, , Chile
University Hospital Kralovske Vinohrady Prague, Prague, , Czech Republic
General University Hospital Prague, Prague, , Czech Republic
Institute of Haematology and Blood Transfusion Prague, Prague, , Czech Republic
Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó, Guayaquil, , Ecuador
Hospital Carlos Andrade Marin, Quito, , Ecuador
Hospital Militar, Quito, , Ecuador
North Estonia Medical Centre Foundation, Tallinn, , Estonia
Hopital de Versailles, Versailles, Le Cheaney, France
Hopital Sud, Amiens, , France
Hopital Edouard Herriot, Lyon, , France
Hopital-DIEU, Paris, , France
Hopital du Haut Leveque, Pessac, , France
Hopital Bretonneau - CHRU de Tours, Tours, , France
Charite - Campus Benjamin Franklin, Berlin, , Germany
Campus Virchow Klinikum, Berlin, , Germany
Evangelische Kliniken GmbH, Bonn, , Germany
St Antonius Hospital, Eschweiler, , Germany
Universitatsklinikum Essen, Essen, , Germany
Stadtische Kliniken Frankfurt, Frankfurt, , Germany
Asklepios Kliniken Altona, Hamburg, , Germany
Medizin Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Schleswig-Holstein, Kiel, , Germany
Klinikum Leverkusen, Leverkusen, , Germany
Markische Kliniken GmbH Klinikim Ludenscheid, Lüdenscheid, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government, Budapest, , Hungary
Petz Aladar County Teaching Hospital, Győr, , Hungary
Kaposi Mór County Teaching Hospital, Kaposvár, , Hungary
University of Pecs, Pecs, , Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Chaim Sheba Medical Center, Tel Hashomer, , Israel
University of Brescia, Brescia, , Italy
A.O.U Careggi, Firenze, , Italy
A.O.U San Martino, Genova, , Italy
A.O. Cardarelli, Napoli, , Italy
A.O. San Salvatore, Pesaro, , Italy
A.O.U Pisana Santa Chiara, Pisa, , Italy
Università degli Studi di Roma "La Sapienza", Roma, , Italy
Ospedale S. Eugenio, Rome, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital in YUHS, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Teaching Hospital of the Medical University in Bialystok, Bialystok, , Poland
Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk, Gdansk, , Poland
Nicolaus Copernicus Provincial Specialist Hospital in Lodz, Lodz, , Poland
Provincial Hospital in Opole, Opole, , Poland
Poznan Stare Miasto Health Care Facility, Poznan, , Poland
Janusz Korczak Provincial Specialist Hospital, Slupsk, , Poland
Military Institue of Health Services, Warsaw, , Poland
Institute of Hematology and Transfusiology, Warsaw, , Poland
Independent Public University Hospital No. 1 in Wroclaw, Wroclaw, , Poland
Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department, Baia Mare, , Romania
Brasov County Emergency Clinical Hospital, Brasov, , Romania
Colentina Clinical Hospital, Internal Medicine Department, Bucharest, , Romania
Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant, Bucharest, , Romania
Coltea Clinical Hospital, Bucharest, , Romania
Sibiu County Clinical Hospital, Internal Clinic II, Sibiu, , Romania
State Medical Institution Republican Hospital n.a. V.A. Baranov, Petrozavodsk, Republic of Karelia, Russian Federation
Municipal Medical Institution Municipal Hospital #1, Cherepovets, , Russian Federation
State Medical Institution Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
State Medical Institution Irkutsk Regional Clinical Hospital, Irkutsk, , Russian Federation
State Medical Institution Territorial Clinical Hospital #1, Khabarovsk, , Russian Federation
State Medical Institution Territorial Clinical Oncological Center, Krasnodar, , Russian Federation
State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences, Moscow, , Russian Federation
Moscow State Medical Institution Municipal, Moscow, , Russian Federation
Municipal Medical Institution, Perm, , Russian Federation
State Higher Educational Instution Rostov State, Rostow Am Don, , Russian Federation
State Medical Institution Leningrad Regional Clinical Hospital, St. Petersburg, , Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, St. Petersburg, , Russian Federation
Federal Center of Heart, Blood and Endocrinology, St. Petersburg, , Russian Federation
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clinic I Provinicial, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Chang Gung Memorial Hospital Kao Hsiung Branch, Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan
Changhua Christian Hospital (CCH), Changhua, , Taiwan
Chinese Medical University Hospital (CMUH), Taichung City, , Taiwan
National Cheng Kung University Hospital (NCKUH), Tainan, , Taiwan
National Taiwan University Hospital (NTUH), Taipei, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Veterans General Hospital Taipei (VGH-TP), Taipei, , Taiwan
Public Institution 'Cherkasy Regional Oncology Center', Cherkasy, , Ukraine
Dnipropetrovsk City General Clinical Hospital #4, Dnipropetrovsk, , Ukraine
Ivano-Frankivsk State Medical University, Ivano-Frankivsk, , Ukraine
Khmelnytsky Regional Hospital, Khmelnytsky, , Ukraine
State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS', Lviv, , Ukraine
Mykolaiv Regional Clinical Hospital, Mykolaiv, , Ukraine
Odesa Regional Clinical Hospital, Odesa, , Ukraine
Ukrainian Medical Academy of Dentistry, Poltava, , Ukraine
M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Vinnytsya, , Ukraine
O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Zhytomyr, , Ukraine
University Hospital of Wales, Cardiff, Wales, United Kingdom
King's College Hospital, London, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Contact Details
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