Spots Global Cancer Trial Database for Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
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: Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
Study ID: NCT01757535
Conditions
Study Description
Brief Summary: This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.
Detailed Description: This is an international, multicenter, placebo-controlled, Phase 3 study with a double-blind, randomized, parallel-group design in subjects with de novo AML or AML secondary to prior diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) aged ≥ 55 years, who are in first CR/CRi following induction therapy with or without consolidation chemotherapy. The study consists of 3 phases; the pre-randomization phase (screening phase), the treatment phase, and the follow-up phase. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine after unblinding by sponsor until they meet the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, P.C., Phoenix, Arizona, United States
Providence St Joseph Medical Center Cancer Center, Burbank, California, United States
City Of Hope, Duarte, California, United States
University of California San Francisco Fresno Campus, Fresno, California, United States
University of Southern California Norris Cancer Center, Los Angeles, California, United States
Ucla, Los Angeles, California, United States
Local Institution - 050, Orange, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Stanford Cancer Center, Stanford, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
The Hospital of Central Connecticut, Southington, Connecticut, United States
George Washington University Cancer Center, Washington, District of Columbia, United States
University Of Florida, Gainesville, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Florida Health Cancer Center at Orlando Health, Orlando, Florida, United States
Northwestern University Medical Center, Chicago, Illinois, United States
Loyola University Chicago, Maywood, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL, Niles, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
Kansas University Medical Center, Westwood, Kansas, United States
University Of Louisville, Louisville, Kentucky, United States
Norton Cancer Institute Louisville Oncology, Louisville, Kentucky, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
Ochsner Medical Center - Jefferson Highway, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Massachusetts, Worcester, Massachusetts, United States
Local Institution - 037, Rochester, Minnesota, United States
Kansas City VA Medical Center University of Kansas Medical Center, Kansas City, Missouri, United States
Washington University School Of Medicine, Saint Louis, Missouri, United States
University Of Nebraska Medical Center, Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Winthrop University Hospital, Mineola, New York, United States
Mt. Sinai Medical Center, New York, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Local Institution - 002, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Local Institution - 014, Valhalla, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Local Institution - 025, Winston-Salem, North Carolina, United States
Local Institution - 016, Cleveland, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Kaiser Permanente Northwest Oncology Hematology, Portland, Oregon, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
UPMC Cancer Pavillion, Pittsburgh, Pennsylvania, United States
Greenville Hospital System, Greenville, South Carolina, United States
Sarah Cannon Research Inst, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University Of Texas Southwestern Medical Center, Dallas, Texas, United States
Brooke-Army Medical Center, Fort Sam Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas - Loop, San Antonio, Texas, United States
Methodist Hospital, San Antonio, Texas, United States
VA Commonwealth University - Massey Cancer Center, Richmond, Virginia, United States
Swedish Cancer Inst, Seattle, Washington, United States
Yakima Valley Memorial Hospital/ North Star Lodge, Yakima, Washington, United States
Froedtert Hospital BMT Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Local Institution - 510, Wollongong, New South Wales, Australia
Local Institution - 509, South Brisbane, Queensland, Australia
Local Institution - 508, Adelaide, South Australia, Australia
Local Institution - 511, Bedford Park, South Australia, Australia
Local Institution - 504, Woodville South, South Australia, Australia
Local Institution - 503, Heidelberg, , Australia
Local Institution - 502, Hobart, , Australia
Local Institution - 507, Liverpool, , Australia
Local Institution - 500, Melbourne, , Australia
Local Institution - 505, Perth, , Australia
Local Institution - 512, Perth, , Australia
Local Institution - 506, St Leonards, , Australia
Local Institution - 501, Woolloongabba, , Australia
Local Institution - 271, Graz, , Austria
Local Institution - 270, Salzburg, , Austria
Local Institution - 274, Vienna, , Austria
Local Institution - 273, Vienna, , Austria
Local Institution - 272, Wien, , Austria
Local Institution - 300, Brugge, , Belgium
Local Institution - 301, Charleroi, , Belgium
Local Institution - 302, Mons, , Belgium
Local Institution - 233, Curitiba, Paraná, Brazil
Local Institution - 231, Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 232, Rio de Janeiro, , Brazil
Local Institution - 230, Sao Paulo, , Brazil
Local Institution - 234, São Paulo, , Brazil
Local Institution - 605, Edmonton, Alberta, Canada
Local Institution - 600, Winnipeg, Manitoba, Canada
Local Institution - 601, Saint John, New Brunswick, Canada
Local Institution - 603, St John's, Newfoundland and Labrador, Canada
Local Institution - 604, Halifax, Nova Scotia, Canada
Local Institution - 607, Toronto, Ontario, Canada
Local Institution - 608, Montreal, Quebec, Canada
Local Institution - 602, Montreal, Quebec, Canada
Local Institution - 320, Brno, Jihomoravský Kraj, Czechia
Local Institution - 321, Praha, , Czechia
Local Institution - 322, Praha, , Czechia
Local Institution - 361, Helsinki, , Finland
Local Institution - 362, Tampere, , Finland
Local Institution - 360, Turku, , Finland
Local Institution - 456, Amiens, , France
Local Institution - 465, Argenteuil, , France
Local Institution - 457, Bobigny Cedex, , France
Local Institution - 462, Boulognes Sur Mer, , France
Local Institution - 460, Clamart Cedex, , France
Local Institution - 452, Creteil, , France
Local Institution - 458, Le Chesnay Cedex, , France
Local Institution - 453, Lille, , France
Local Institution - 461, Limoges Cedex, , France
Local Institution - 450, Lyon cedex, , France
Local Institution - 800, Paris Cedex 10, , France
Local Institution - 463, Paris, , France
Local Institution - 454, Paris, , France
Local Institution - 464, Pontoise, , France
Local Institution - 455, Rouen, , France
Local Institution - 459, Saint-Cloud, , France
Local Institution - 451, Villejuif CEDEX, , France
Local Institution - 400, Dresden, Saxony, Germany
Local Institution - 413, Berlin, , Germany
Local Institution - 410, Bonn, , Germany
Local Institution - 406, Düsseldorf, , Germany
Local Institution - 415, Erlangen, , Germany
Local Institution - 404, Frankfurt am Main, , Germany
Local Institution - 412, Goch, , Germany
Local Institution - 405, Hannover, , Germany
Local Institution - 408, Heilbronn, , Germany
Local Institution - 414, Jena, , Germany
Local Institution - 403, Keil, , Germany
Local Institution - 402, Mannheim, , Germany
Local Institution - 409, Muenchen, , Germany
Local Institution - 411, München, , Germany
Local Institution - 407, Oldenburg, , Germany
Local Institution - 416, Schweiler, , Germany
Local Institution - 401, Ulm, , Germany
Local Institution - 950, Dublin, , Ireland
Local Institution - 951, Galway, , Ireland
Local Institution - 381, Beer Sheva, , Israel
Local Institution - 380, Haifa, , Israel
Local Institution - 383, Jerusalem, , Israel
Local Institution - 382, Petach Tikva, , Israel
Local Institution - 701, Alessandria, , Italy
Local Institution - 721, Bari, , Italy
Local Institution - 720, Bologna, , Italy
Local Institution - 710, Cagliari, , Italy
Local Institution - 702, Cremona, , Italy
Local Institution - 708, Firenze, , Italy
Local Institution - 712, Genova, , Italy
Local Institution - 716, Lecce, , Italy
Local Institution - 726, Milano, , Italy
Local Institution - 706, Milan, , Italy
Local Institution - 704, Monza, , Italy
Local Institution - 717, Naples, , Italy
Local Institution - 725, Naples, , Italy
Local Institution - 705, Orbassano (TO), , Italy
Local Institution - 703, Palermo, , Italy
Local Institution - 719, Palermo, , Italy
Local Institution - 724, Pesaro, , Italy
Local Institution - 700, Reggio Calabria, , Italy
Local Institution - 709, Roma, , Italy
Local Institution - 714, Roma, , Italy
Local Institution - 723, Roma, , Italy
Local Institution - 722, Rome, , Italy
Local Institution - 715, Torino, , Italy
Local Institution - 718, Torino, , Italy
Local Institution - 711, Udine, , Italy
Local Institution - 707, Varese, , Italy
Local Institution - 535, Busan, , Korea, Republic of
Local Institution - 533, Daegu, , Korea, Republic of
Local Institution - 536, Seoul, , Korea, Republic of
Local Institution - 530, Seoul, , Korea, Republic of
Local Institution - 531, Seoul, , Korea, Republic of
Local Institution - 532, Seoul, , Korea, Republic of
Local Institution - 750, Klaipeda, , Lithuania
Local Institution - 252, Huixquilucan de Degollado, , Mexico
Local Institution - 251, Mexico, , Mexico
Local Institution - 250, Monterrey, , Mexico
Local Institution - 824, Bydgoszcz, , Poland
Local Institution - 820, Gdansk, , Poland
Local Institution - 822, Lodz, , Poland
Local Institution - 821, Warsaw, , Poland
Local Institution - 823, Wroclaw, , Poland
Local Institution - 841, Coimbra, , Portugal
Local Institution - 840, Lisboa, , Portugal
Local Institution - 843, Lisboa, , Portugal
Local Institution - 842, Porto, , Portugal
Local Institution - 844, Porto, , Portugal
Local Institution - 971, Moscow, , Russian Federation
Local Institution - 970, Nizhniy Novgorod, , Russian Federation
Local Institution - 972, Saint Petersburg, , Russian Federation
Local Institution - 973, St Petersburg, , Russian Federation
Local Institution - 872, Palma de Mallorca, Baleares, Spain
Local Institution - 869, Badalona (Barcelona), , Spain
Local Institution - 871, Barcelona, , Spain
Local Institution - 870, Barcelona, , Spain
Local Institution - 873, Caceres, , Spain
Local Institution - 863, Cordoba, , Spain
Local Institution - 867, La Coruna, , Spain
Local Institution - 868, Madrid, , Spain
Local Institution - 866, Madrid, , Spain
Local Institution - 865, Madrid, , Spain
Local Institution - 864, Oviedo, , Spain
Local Institution - 861, Salamanca, , Spain
Local Institution - 862, Sevilla, , Spain
Local Institution - 860, Valencia, , Spain
Local Institution - 599, Beitou District, Taipei City, , Taiwan
Local Institution - 595, Niaosong District Kaohsiung City, , Taiwan
Local Institution - 596, Taichung, Northern Dist., , Taiwan
Local Institution - 597, Tainan, Taiana, , Taiwan
Local Institution - 598, Taipei, Zhongzheng Dist., , Taiwan
Local Institution - 653, Ankara, , Turkey
Local Institution - 650, Ankara, , Turkey
Local Institution - 651, Istanbul, , Turkey
Local Institution - 652, Samsun, , Turkey
Local Institution - 904, Nottingham, Nottinghamshire, United Kingdom
Local Institution - 907, Boston, , United Kingdom
Local Institution - 903, Brighton East Sussex, , United Kingdom
Local Institution - 902, Canterbury Kent, , United Kingdom
Local Institution - 905, London, , United Kingdom
Local Institution - 901, London, , United Kingdom
Local Institution - 908, London, , United Kingdom
Local Institution - 909, Maidstone, , United Kingdom
Local Institution - 900, Manchester, , United Kingdom
Local Institution - 906, Romford, Essex, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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:
