Acute Myeloid Leukemia Clinical Trial

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Male or female participants ≥ 55 years of age
Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

Key Inclusion Criteria in the Extended Phase of the study:

At the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase:

All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study;

Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP);
Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP;
Participants currently in the follow-up phase will continue to be followed for survival in the EP;
Participants who have signed the informed consent for the EP of the study;
Participants who do not meet any of the criteria for study discontinuation

Key Exclusion Criteria:

AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
Prior bone marrow or stem cell transplantation
Have achieved CR/CRi following therapy with hypomethylating agents
Diagnosis of malignant disease within the previous 12 months
Proven central nervous system (CNS) leukemia

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

472

Study ID:

NCT01757535

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 213 Locations for this study

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Arizona Oncology Associates, P.C.
Phoenix Arizona, 85016, United States
Providence St Joseph Medical Center Cancer Center
Burbank California, 91505, United States
City of Hope
Duarte California, 91010, United States
University of California San Francisco Fresno Campus
Fresno California, 93701, United States
University of Southern California Norris Cancer Center
Los Angeles California, 90033, United States
UCLA
Los Angeles California, 90095, United States
UC Irvine
Orange California, 92868, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Stanford Cancer Center
Stanford California, 94305, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
The Hospital of Central Connecticut
Southington Connecticut, 06489, United States
George Washington University Cancer Center
Washington District of Columbia, 20037, United States
University of Florida
Gainesville Florida, 32610, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
University of Florida Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Northwestern University Medical Center Division of Hematology Oncology
Chicago Illinois, 60611, United States
Loyola University Chicago
Maywood Illinois, 60153, United States
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
Niles Illinois, 60714, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
Kansas University Medical Center
Westwood Kansas, 66205, United States
University of Louisville
Louisville Kentucky, 40202, United States
Norton Cancer Institute Louisville Oncology
Louisville Kentucky, 40207, United States
Tulane University Medical Center
New Orleans Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University of Massachusetts
Worcester Massachusetts, 01655, United States
Local Institution - 037
Rochester Minnesota, 55905, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City Missouri, 64128, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Winthrop University Hospital
Mineola New York, 11501, United States
Mt. Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Weill Cornell Medical College
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
New York Medical College
Valhalla New York, 10595, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Kaiser Permanente Northwest Oncology Hematology
Portland Oregon, 97227, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
UPMC Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
Greenville Hospital System
Greenville South Carolina, 29605, United States
Sarah Cannon Research Inst
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Brooke-Army Medical Center
Fort Sam Houston Texas, 78234, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Care Centers of South Texas - Loop
San Antonio Texas, 78217, United States
Methodist Hospital
San Antonio Texas, 78229, United States
VA Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Swedish Cancer Inst
Seattle Washington, 98104, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima Washington, 98902, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Mater Private Medical Centre Haematology and Oncology Clinics of Australasia Research Centre
South Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, SA 50, Australia
Flinders Medical Centre, Dept Of Oncology
Bedford Park South Australia, 5042, Australia
Austin Hospital
Heidelberg , 3084, Australia
Royal Hobart Hospital
Hobart , 7000, Australia
Liverpool Hospital
Liverpool , 2170, Australia
The Alfred Hospital
Melbourne , 3004, Australia
Royal Perth Hospital
Perth , 6000, Australia
Local Institution - 506
St Leonards , 2065, Australia
Royal North Shore Hospital
St Leonards , 2065, Australia
Wollongong Hospital
Wollongong , 2500, Australia
The Queen Elizabeth Hospital
Woodville South , 5011, Australia
Local Institution - 501
Woolloongabba , 4102, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Medical University of Graz
Graz , A-803, Austria
University Hospital of Salzburg
Salzburg , 5020, Austria
KH Hietzing
Vienna , 1130, Austria
Medical University of Vienna
Vienna , 1190, Austria
Hanusch Krankenhaus
Wien , 1140, Austria
AZ St-Jan Brugge Oostende AV
Brugge , 8000, Belgium
Grand Hopital de Charleroi
Charleroi , 6000, Belgium
Center Hospitalier Universitaire Ambroise Pare
Mons , 7000, Belgium
Hospital de Clínicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Local Institution - 231
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital Erasto Gaertner
Curitiba , 81520, Brazil
Instituto Nacional de Cancer - INCA
Rio de Janeiro , 20230, Brazil
Saint Petersburg Medical State Institution Municipal n.a. I.P. Pavlov
Saint Petersburg , 19602, Brazil
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
Sao Paulo , 05651, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo , 01308, Brazil
University of Alberta
Edmonton Alberta, T6G 2, Canada
Cancer Care Manitoba
Winnipeg Manitoba, R3E O, Canada
Regional Health Authority B-Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Health Sciences Center
St John's Newfoundland and Labrador, A1B3V, Canada
Queen Elizabeth II Health Sciences Center
Halifax Nova Scotia, B3H 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Local Institution - 608
Montreal Quebec, H2W 1, Canada
McGill University, Dept. Oncology Clinical Research Program
Montreal Quebec, H2W 1, Canada
Hopital du Sacre-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Local Institution - 320
Brno Jihomoravský Kraj, 625 0, Czechia
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Local Institution - 321
Praha , 128 0, Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha , 128 0, Czechia
Ustav hematologie a krevni transfuze
Praha , 128 2, Czechia
Helsinki University Central Hospital
Helsinki , 290, Finland
Local Institution - 361
Helsinki , 290, Finland
University HospitaClinik of internal medicin
Tampere , 33521, Finland
Turku University Hospital
Turku , 20521, Finland
Hopital Sud, CHU d'Amiens
Amiens , 80054, France
CH Argenteuil Victor Dupouy
Argenteuil , 95100, France
Hopital Avicenne
Bobigny Cedex , 93009, France
Centre hospitalier de Boulognes - Duchenne
Boulognes Sur Mer , 62200, France
Hopital dinstruction des armees Percy
Clamart Cedex , 92141, France
Hopital Henri Mondor
Creteil , 94010, France
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay Cedex , 78157, France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille , 59037, France
Local Institution - 453
Lille , 59037, France
CHU Limoges
Limoges Cedex , 87042, France
CHU Hopital Edouard Herriot
Lyon cedex , 69437, France
Hopital Saint Louis
Paris Cedex 10 , 75475, France
Hospital of Necker
Paris , 75015, France
Hopital Saint Louis
Paris , 75475, France
Centre Hospitalier Pontoise Rene Dubos
Pontoise , 95301, France
Centre Henri Becquerel
Rouen , 76038, France
Institut Curie
Saint-Cloud , 92210, France
Institut Gustave Roussy
Villejuif Cedex , 94805, France
Local Institution - 451
Villejuif CEDEX , 94805, France
Local Institution - 400
Dresden Saxony, 01307, Germany
Charite - Universitätsmedizin Berlin
Berlin , 12203, Germany
Universitaetsklinikum Bonn
Bonn , 53127, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
University Duesseldorf
Düsseldorf , 40225, Germany
Universitaetsklinikum Erlangen
Erlangen , 91054, Germany
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main , 65929, Germany
Wilhelm-Anton-Hospital Goch gGmbH Hämatologie und Internistische Onkologie
Goch , 47574, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn , 74078, Germany
Universitatsklinikum Jena
Jena , 07740, Germany
Universitatsklinikum Schleswig-Holstein
Keil , 24105, Germany
Universitaetsklinikum Mannheim
Mannheim , 68167, Germany
Staedtisches Klinikum Muenchen Schwabing
Muenchen , 80804, Germany
TU München - Klinikum rechts der Isar
München , 81675, Germany
Klinikum Oldenburg gGmbH
Oldenburg , 26133, Germany
St. Antonius-Hospital
Schweiler , 52249, Germany
University of Ulm
Ulm , 89081, Germany
Tallaght Adelaide and Meath Hospital
Dublin , 24, Ireland
University College Hospital Galway
Galway , ST46Q, Ireland
Soroka University Medical Center
Beer Sheva , 84101, Israel
Rambam Medical Center
Haifa , 35254, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Rabin Medical Center
Petach Tikva , 49100, Israel
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria , 15121, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari , 70124, Italy
Policlinico Sant'Orsola-Malpighi
Bologna , 40138, Italy
Ospedale Bingaghi
Cagliari , O9126, Italy
Istituti Ospitalieri di Cremona
Cremona , 26100, Italy
Azienda Ospedaliero Universitaria Careggi
Firenze , 50129, Italy
IRCCS AziendaOspedaliera Universitaria San Martino
Genova , 16132, Italy
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce , 73100, Italy
Local Institution - 716
Lecce , 73100, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milano , 20162, Italy
Fondazione Ca Granda IRCCS Ospedale Maggiore
Milan , 20122, Italy
Ospedale S. Gerardo di Monza
Monza , 20900, Italy
Azienda ospedeliera della 2 Universita di Napoli
Naples , 80131, Italy
Ospedale Cardarelli
Naples , 80131, Italy
AOU San Luigi Gonzaga
Orbassano (TO) , 10043, Italy
Local Institution - 705
Orbassano (TO) , 10043, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo , 90146, Italy
Casa di Cura La Maddalena, Divisione di Ematologia
Palermo , 90146, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN
Pesaro , 31122, Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria , 89100, Italy
Local Institution - 700
Reggio Calabria , 89100, Italy
Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I
Roma , 00161, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma , 00189, Italy
Local Institution - 723
Roma , 00189, Italy
Local Institution - 722
Rome , 133, Italy
University Hospital Tor Vergata
Rome , 133, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine , 33100, Italy
A.O. Universitaria Fondazione Macchi
Varese , 21100, Italy
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Kyungpook National University Hospital
Daegu , 700-7, Korea, Republic of
Local Institution - 536
Seoul , 120-7, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul , 137-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Local Institution - 532
Seoul , 138-7, Korea, Republic of
Klaipeda seaman hospital
Klaipeda , 5809, Lithuania
Hospital Angeles Lomas - Consultorio 830
Huixquilucan de Degollado , 52763, Mexico
Instituto Nacional de Cancerología
Mexico , 14080, Mexico
Hospital Universitario Eleuterio Gomez
Monterrey , 64460, Mexico
Local Institution - 250
Monterrey , 64460, Mexico
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz , 85-16, Poland
Institute of Internal Diseases University of Medicine
Gdansk , 80-21, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Institute of Hematology and Transfusion Medicine
Warsaw , 02-77, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw , 50-36, Poland
Centro Hospital e Universitario de Coimbra
Coimbra , 4200-, Portugal
Local Institution - 841
Coimbra , 4200-, Portugal
Instituto Portugues de Oncologia de Lisboa
Lisboa , 1099-, Portugal
Local Institution - 840
Lisboa , 1099-, Portugal
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa , 1150-, Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto , 4200-, Portugal
Hospital de Sao Joao
Porto , 4200, Portugal
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow , 12510, Russian Federation
Nizhniy Novgorod State Medical Academy of Roszdrav
Nizhniy Novgorod , 60300, Russian Federation
Local Institution - 972
Saint Petersburg , 19602, Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg , 19734, Russian Federation
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona) , 8916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 8035, Spain
Hospital de San Pedro de Alcantara
Caceres , 10003, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Complejo Universitario La Coruna
La Coruna , 15006, Spain
Hospital Universitario La Princesa
Madrid , 28006, Spain
Hospital Universitario Gregorio Maranon
Madrid , 28007, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Central de Asturias
Oviedo , 33006, Spain
Hospital Son Llatzer
Palma de Mallorca , 7198, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Virgen del Rocio
Sevilla , 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Local Institution - 860
Valencia , 46026, Spain
Taipei Veterans General Hospital
Beitou District, Taipei City , 11217, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Niaosong District Kaohsiung City , 83301, Taiwan
China Medical University Hospital
Taichung, Northern Dist. , 404, Taiwan
National Cheng Kung University Hospital
Tainan, Taiana , 704, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist. , 100, Taiwan
Hacettepe Universitesi
Ankara , 06100, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital
Ankara , 06200, Turkey
Marmara School of Medicine
Istanbul , 34662, Turkey
Ondokuz Mayis University Medical Faculty
Samsun , 55139, Turkey
Local Institution - 904
Nottingham Nottinghamshire, NG5 1, United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston , PE21 , United Kingdom
Royal Sussex County Hospital
Brighton East Sussex , BN2 5, United Kingdom
Kent and Canterbury Hospital
Canterbury Kent , CT1 3, United Kingdom
University College London Hospitals
London , NW1 2, United Kingdom
Kings College Hospital
London , SE5 9, United Kingdom
Imperial College Hammersmith Hospital
London , W12 0, United Kingdom
Maidstone Hospital
Maidstone Kent , ME16 , United Kingdom
Christie NHS Trust Hospital
Manchester , M20 4, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, Essex , RM7 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

472

Study ID:

NCT01757535

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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