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 214 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
Local Institution - 050
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
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 Medical Center - Jefferson Highway
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, 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
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 Irving Medical Center
New York New York, 10032, United States
Local Institution - 002
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Local Institution - 014
Valhalla New York, 10595, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Local Institution - 025
Winston-Salem North Carolina, 27157, United States
Local Institution - 016
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
Local Institution - 510
Wollongong New South Wales, 2500, Australia
Local Institution - 509
South Brisbane Queensland, 4101, Australia
Local Institution - 508
Adelaide South Australia, SA 50, Australia
Local Institution - 511
Bedford Park South Australia, 5042, Australia
Local Institution - 504
Woodville South South Australia, 5011, Australia
Local Institution - 503
Heidelberg , 3084, Australia
Local Institution - 502
Hobart , 7000, Australia
Local Institution - 507
Liverpool , 2170, Australia
Local Institution - 500
Melbourne , 3004, Australia
Local Institution - 505
Perth , 6000, Australia
Local Institution - 512
Perth , 6000, Australia
Local Institution - 506
St Leonards , 2065, Australia
Local Institution - 501
Woolloongabba , 4102, Australia
Local Institution - 271
Graz , 73013, Austria
Local Institution - 270
Salzburg , 5020, Austria
Local Institution - 274
Vienna , 1130, Austria
Local Institution - 273
Vienna , 1190, Austria
Local Institution - 272
Wien , 1140, Austria
Local Institution - 300
Brugge , 8000, Belgium
Local Institution - 301
Charleroi , 6000, Belgium
Local Institution - 302
Mons , 7000, Belgium
Local Institution - 233
Curitiba Paraná, 81520, Brazil
Local Institution - 231
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Local Institution - 232
Rio de Janeiro , 20230, Brazil
Local Institution - 230
Sao Paulo , 05651, Brazil
Local Institution - 234
São Paulo , 01308, Brazil
Local Institution - 605
Edmonton Alberta, T6G 2, Canada
Local Institution - 600
Winnipeg Manitoba, R3E O, Canada
Local Institution - 601
Saint John New Brunswick, E2L 4, Canada
Local Institution - 603
St John's Newfoundland and Labrador, A1B3V, Canada
Local Institution - 604
Halifax Nova Scotia, B3H 2, Canada
Local Institution - 607
Toronto Ontario, M5G 2, Canada
Local Institution - 608
Montreal Quebec, H2W 1, Canada
Local Institution - 602
Montreal Quebec, H4J 1, Canada
Local Institution - 320
Brno Jihomoravský Kraj, 625 0, Czechia
Local Institution - 321
Praha , 128 0, Czechia
Local Institution - 322
Praha , 128 2, Czechia
Local Institution - 361
Helsinki , 290, Finland
Local Institution - 362
Tampere , 33521, Finland
Local Institution - 360
Turku , 20521, Finland
Local Institution - 456
Amiens , 80054, France
Local Institution - 465
Argenteuil , 95100, France
Local Institution - 457
Bobigny Cedex , 93009, France
Local Institution - 462
Boulognes Sur Mer , 62200, France
Local Institution - 460
Clamart Cedex , 92141, France
Local Institution - 452
Creteil , 94010, France
Local Institution - 458
Le Chesnay Cedex , 78157, France
Local Institution - 453
Lille , 59037, France
Local Institution - 461
Limoges Cedex , 87042, France
Local Institution - 450
Lyon cedex , 69437, France
Local Institution - 800
Paris Cedex 10 , 75475, France
Local Institution - 463
Paris , 75015, France
Local Institution - 454
Paris , 75475, France
Local Institution - 464
Pontoise , 95301, France
Local Institution - 455
Rouen , 76038, France
Local Institution - 459
Saint-Cloud , 92210, France
Local Institution - 451
Villejuif CEDEX , 94805, France
Local Institution - 400
Dresden Saxony, 01307, Germany
Local Institution - 413
Berlin , 12203, Germany
Local Institution - 410
Bonn , 53127, Germany
Local Institution - 406
Düsseldorf , 40225, Germany
Local Institution - 415
Erlangen , 91054, Germany
Local Institution - 404
Frankfurt am Main , 65929, Germany
Local Institution - 412
Goch , 47574, Germany
Local Institution - 405
Hannover , 30625, Germany
Local Institution - 408
Heilbronn , 74078, Germany
Local Institution - 414
Jena , 07740, Germany
Local Institution - 403
Keil , 24105, Germany
Local Institution - 402
Mannheim , 68167, Germany
Local Institution - 409
Muenchen , 80804, Germany
Local Institution - 411
München , 81675, Germany
Local Institution - 407
Oldenburg , 26133, Germany
Local Institution - 416
Schweiler , 52249, Germany
Local Institution - 401
Ulm , 89081, Germany
Local Institution - 950
Dublin , 24, Ireland
Local Institution - 951
Galway , ST46Q, Ireland
Local Institution - 381
Beer Sheva , 84101, Israel
Local Institution - 380
Haifa , 35254, Israel
Local Institution - 383
Jerusalem , 91120, Israel
Local Institution - 382
Petach Tikva , 49100, Israel
Local Institution - 701
Alessandria , 15121, Italy
Local Institution - 721
Bari , 70124, Italy
Local Institution - 720
Bologna , 40138, Italy
Local Institution - 710
Cagliari , O9126, Italy
Local Institution - 702
Cremona , 26100, Italy
Local Institution - 708
Firenze , 50129, Italy
Local Institution - 712
Genova , 16132, Italy
Local Institution - 716
Lecce , 73100, Italy
Local Institution - 726
Milano , 20162, Italy
Local Institution - 706
Milan , 20122, Italy
Local Institution - 704
Monza , 20900, Italy
Local Institution - 717
Naples , 80131, Italy
Local Institution - 725
Naples , 80131, Italy
Local Institution - 705
Orbassano (TO) , 10043, Italy
Local Institution - 703
Palermo , 90146, Italy
Local Institution - 719
Palermo , 90146, Italy
Local Institution - 724
Pesaro , 31122, Italy
Local Institution - 700
Reggio Calabria , 89100, Italy
Local Institution - 709
Roma , 00161, Italy
Local Institution - 714
Roma , 00168, Italy
Local Institution - 723
Roma , 00189, Italy
Local Institution - 722
Rome , 133, Italy
Local Institution - 715
Torino , 10126, Italy
Local Institution - 718
Torino , 10126, Italy
Local Institution - 711
Udine , 33100, Italy
Local Institution - 707
Varese , 21100, Italy
Local Institution - 535
Busan , 49241, Korea, Republic of
Local Institution - 533
Daegu , 700-7, Korea, Republic of
Local Institution - 536
Seoul , 120-7, Korea, Republic of
Local Institution - 530
Seoul , 135-7, Korea, Republic of
Local Institution - 531
Seoul , 137-7, Korea, Republic of
Local Institution - 532
Seoul , 138-7, Korea, Republic of
Local Institution - 750
Klaipeda , 5809, Lithuania
Local Institution - 252
Huixquilucan de Degollado , 52763, Mexico
Local Institution - 251
Mexico , 14080, Mexico
Local Institution - 250
Monterrey , 64460, Mexico
Local Institution - 824
Bydgoszcz , 85-16, Poland
Local Institution - 820
Gdansk , 80-21, Poland
Local Institution - 822
Lodz , 93-51, Poland
Local Institution - 821
Warsaw , 02-77, Poland
Local Institution - 823
Wroclaw , 50-36, Poland
Local Institution - 841
Coimbra , 4200-, Portugal
Local Institution - 840
Lisboa , 1099-, Portugal
Local Institution - 843
Lisboa , 1150-, Portugal
Local Institution - 842
Porto , 4200-, Portugal
Local Institution - 844
Porto , 4200, Portugal
Local Institution - 971
Moscow , 12510, Russian Federation
Local Institution - 970
Nizhniy Novgorod , 60300, Russian Federation
Local Institution - 972
Saint Petersburg , 19602, Russian Federation
Local Institution - 973
St Petersburg , 19734, Russian Federation
Local Institution - 872
Palma de Mallorca Baleares, 07198, Spain
Local Institution - 869
Badalona (Barcelona) , 8916, Spain
Local Institution - 871
Barcelona , 08025, Spain
Local Institution - 870
Barcelona , 08035, Spain
Local Institution - 873
Caceres , 10003, Spain
Local Institution - 863
Cordoba , 14004, Spain
Local Institution - 867
La Coruna , 15006, Spain
Local Institution - 868
Madrid , 28006, Spain
Local Institution - 866
Madrid , 28007, Spain
Local Institution - 865
Madrid , 28040, Spain
Local Institution - 864
Oviedo , 33006, Spain
Local Institution - 861
Salamanca , 37007, Spain
Local Institution - 862
Sevilla , 41013, Spain
Local Institution - 860
Valencia , 46026, Spain
Local Institution - 599
Beitou District, Taipei City , 11217, Taiwan
Local Institution - 595
Niaosong District Kaohsiung City , 83301, Taiwan
Local Institution - 596
Taichung, Northern Dist. , 404, Taiwan
Local Institution - 597
Tainan, Taiana , 704, Taiwan
Local Institution - 598
Taipei, Zhongzheng Dist. , 10002, Taiwan
Local Institution - 653
Ankara , 06100, Turkey
Local Institution - 650
Ankara , 06200, Turkey
Local Institution - 651
Istanbul , 34662, Turkey
Local Institution - 652
Samsun , 55139, Turkey
Local Institution - 904
Nottingham Nottinghamshire, NG5 1, United Kingdom
Local Institution - 907
Boston , PE21 , United Kingdom
Local Institution - 903
Brighton East Sussex , BN2 5, United Kingdom
Local Institution - 902
Canterbury Kent , CT1 3, United Kingdom
Local Institution - 905
London , NW1 2, United Kingdom
Local Institution - 901
London , SE5 9, United Kingdom
Local Institution - 908
London , W12 0, United Kingdom
Local Institution - 909
Maidstone , ME16 , United Kingdom
Local Institution - 900
Manchester , M20 4, United Kingdom
Local Institution - 906
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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