Spots Global Cancer Trial Database for Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)
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Trial Identification
Brief Title: Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)
Official Title: A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia
Study ID: NCT01147939
Conditions
Study Description
Brief Summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).
Detailed Description: The study investigates the new nucleoside analogue derivative, elacytarabine, as treatment for patients with relapsed or refractory Acute Myeloid Leukemia (AML). To be included in the study, patients must have failed to respond to two or three different therapies for AML, or have obtained remission but then relapsed within a relatively short period of time. Patients of age ≥ 65 with adverse cytogenetics can be included in the study after having received one and up to three previous induction/re-induction therapies. Elacytarabine is an investigational drug which is not commercially available. It is the elaidic acid ester derivative of cytarabine. Cytarabine is routinely used in the treatment of patients with AML. A substantial portion of AML patients have a deficient uptake of cytarabine, often explained by lack of a transport protein (hENT1) in the leukemic cell membrane. Due to the elaidic acid (a naturally occurring fatty acid), cellular uptake of elacytarabine is independent of this transport protein. Patients included in the study will be randomized to elacytarabine or control treatment. Since there is no standard therapy for relapsed or refractory AML, there is a list of 7 control treatments and the investigator has to choose one that is locked before randomization. Elacytarabine is given as a continuous infusion over five days, followed by a rest period of minimum two weeks. Investigator's choice treatment is given according to the specific routine. After each course response evaluation and a decision on further treatment will be made. Repeated courses of elacytarabine and control treatment might be needed to attain and/or maintain complete remission or clinical benefit. After the end of study treatment, all patients will be followed for relapse and survival.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scripps Cancer Center Clinical Research, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
UCLA School of Medicine, Division of Hematology/Oncology, Los Angeles, California, United States
Rocky Mountain Blood and Bone Marrow Transplant Program, Denver, Colorado, United States
Shands at the University of Florida, Gainesville, Florida, United States
Winship Cancer Institute at Emory, Atlanta, Georgia, United States
The Blood and Marrow Transplant Group of GA, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
St. Francis Hospital and Health Center, Indianapolis, Indiana, United States
University of Iowa Hopsitals, Iowa City, Iowa, United States
LSU Health Sciences Center,, Shreveport, Louisiana, United States
Northern New Jersey Cancer Associates, Hackensack, New Jersey, United States
New York Presbyterian Hospital, Weill-Cornell Medical College, New York, New York, United States
Memorial Sloan-Kettering, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University, Health Sciences Section on Hematology and Oncology, Winston-Salem, North Carolina, United States
The Jewish Hospital, Cincinnati, Ohio, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
St. Francis Hospital, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Froedtert Hospital, Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Royal North Shore Hopsital, Sydney, New South Wales, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Box Hill Hospital, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
UZ Brussel, Brussels, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
University Hospital Antwerp, Edegem, , Belgium
CHU Liège, Liège, , Belgium
UCL Mont-Godinne, Yvoir, , Belgium
Princess Margaret Hospital, Toronto, Ontario, Canada
CHU Limoges - Hôpital Dupuytren, Limoges, , France
Hopital Edouard Herriot, Lyon, , France
Institut J. Paoli and I. Calmettes, Marseilles, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Saint Antoine, Paris, , France
CHU de Bordeaux - Hopital Haut-Leveque, Pessac, , France
CHU de Toulouse - Hôpital Purpan, Toulouse, , France
Charité-Campus B. Franklin Med. Klinik Haematology, Berlin, , Germany
Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH, Bonn, , Germany
Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie, Düsseldorf, , Germany
III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie, Mainz, , Germany
Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A, Münster, , Germany
Universitätsklinikum Rostock, Rostock, , Germany
Robert-Bosch-Krankenhaus, Abt.Hämatologie,Onkologie u.Palliativmedizin, Stuttgart, , Germany
Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU), Ulm, , Germany
St James's Hospital Dublin, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
A.O.U Careggi, Firenze, , Italy
A.O San Martino, Genova, , Italy
Fondazione San Raffaele del Monte Tabor, Milano, , Italy
A.O. Cardarelli, Napoli, , Italy
Hospital S. Maria delle Croci, Ravenna, , Italy
Fondazion Policlin T Vergata, Roma, , Italy
Haukeland Universitetssykehus, Bergen, , Norway
Oslo University Hospital, Oslo, , Norway
St Olavs Hospital, Trondheim, , Norway
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, , Poland
Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant, Bucharest, , Romania
Oncology Institute ,,Ion Chiricuta" Cluj Napoca , Hematology dept., Cluj Napoca, , Romania
St. Spiridon" University Hospital, Hematology Department, Iasi, , Romania
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Universitari Son Dureta, Palma de Mallorca, , Spain
Hospital de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario La Fé, Servicio de Hematología, Valencia, , Spain
Gartnavel General Hospital: Beatson WOS Cancer Centre, Glasgow, Scotland, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Christie Hospital, Haematology and Transplant Day Unit, Manchester, , United Kingdom
Contact Details
Name: David Rizzieri, MD
Affiliation: Duke University Medical Center, Durham, NC, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Francis J Giles, MD, PhD
Affiliation: Cancer Therapy & Reseach Center at the University of Texas Health Science Center San Antonio, TX, USA
Role: STUDY_CHAIR
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