Spots Global Cancer Trial Database for A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT01303796
Conditions
Study Description
Brief Summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Detailed Description: This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.
Keywords
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
Scripps Cancer Center, La Jolla, California, United States
UCLA Ronald Reagan Medical Center, Los Angeles, California, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Shands Cancer Hospital at University of Florida, Gainesville, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Maryland Greenbaum Cancer Center, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
St. Louis University Cancer Center, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth - Hitchcock Medical Center, Lebanon, New Hampshire, United States
John Theurer Cancer Center at the Hackensack University Medical Center, Hackensack, New Jersey, United States
Westchester Hematology Oncology Group, PC, Hawthorne, New York, United States
Beth Israel Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medizinische Universitaetsklinik, Innsbruck, , Austria
Elisabethinen Krankenhaus, Linz, , Austria
Krankenhaus der Barmherzigen Schwestern, Linz, , Austria
Univ. Klinik fur Innere Medizin III LKH, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
AKH Wien, Wien, , Austria
Hanusch Krankenhaus, Wien, , Austria
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerpen, , Belgium
AZ Sint-Jan Brugge-Oostende, Brugge, , Belgium
Universite Catholique de Louvain, Brussels, , Belgium
Centre Hospitalier De Jolimont-Lobbes, La Louviere, , Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir, , Belgium
CHU d'Amiens Hopital Sud, Amiens, , France
Centre Hospitalier de la Cote Basque, Bayonne, , France
CHU de Lyon - Hopital Edouard Herriot, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CHRU De Montpellier Hopital St. Eloi, Montpellier, , France
Centre Hospitalier De Mulhouse, Mulhouse, , France
Hopital St Louis Universite Paris 7, Paris, , France
Centre Hospitalier de Perigueux, Perigueux, , France
Centre Hospitalier d'Annecy, Pringy, , France
Centre Hospitalier de Saint-Brieuc Yves Ie Foll, St Brieuc, , France
CHU de Strasbourg - Hopital Civil, Strasbourg, , France
Strasbourg Oncologie Liberale, Strasbourg, , France
CHU de Tours Hopital Bretonneau, Tours, , France
Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin, Berlin, , Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden, Dresden, , Germany
St. Johannes Hospital, Duisburg, , Germany
Klinikum Frankfurt Hoechst, Frankfurt, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK Kliniken Heilbronn, Heilbronn, , Germany
Klinikum St. Georg, Leipzig, , Germany
Johannes Wesling Klinikum, Minden, , Germany
TU Muenchen, Muenchen, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
University of Debrecen, Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz, Győr, , Hungary
Kaposi Mor Oktato Korhaz, Kaposvár, , Hungary
AOU Ospedali Riuniti Umberto I, Ancona, , Italy
AO Ospedali Riuniti di Bergamo, Bergamo, , Italy
Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli, Bologna, , Italy
AO Spedali Civili di Brescia, Brescia, , Italy
Universita Cattolica del Sacro Cuore, Campobasso, , Italy
AOU Careggi, Firenze, , Italy
AOU San Martino IST, Genova, , Italy
PO Vito Fazzi, Lecce, , Italy
Ospedale San Raffaele, Milano, , Italy
AORN Antonio Cardarelli, Napoli, , Italy
Uni. Napoli Ospedale Federico lI, Napoli, , Italy
AOU Maggiore della Carità di Novara, Novara, , Italy
AOOR Villa Sofia Cervello di Palermo, Palermo, , Italy
Policlinico San Matteo Di Pavia, Pavia, , Italy
AOU San Luigi Gonzaga, Torino, , Italy
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku, Gdansk, , Poland
Wojewodzki Szpital Specjalistyczny, Legnica, , Poland
Wojewódzki Szpital Specjalistyczny w Legnicy, Legnica, , Poland
University of Lodz N. Copernicus Memorial Hospital, Lodz, , Poland
IHT Instytut Hematologii I Transfuzjologii w Warszawie, Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu, Wroclaw, , Poland
Hospital Universitari Germans Trias i Pujol ICO Badalona, Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital De La Santa Creu Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de Canarias, La Laguna, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Hospital Universitari Son Espases, Palma de Mallorca, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Clinico Universitario, Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari "La Fe", Valencia, , Spain
Sunderby Hospital, Luleå, , Sweden
Skåne Universitetssjukhus Univ Hospital Lund, Lund, , Sweden
Inselspital Bern, Bern, , Switzerland
Kings College Hospital and Guys and St Thomas' Hospital, London, , United Kingdom
Contact Details
Name: Hagop M Kantarjian, M.D.
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
