Clinical trial NCT01757535: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Myeloid, Acute
Keywords: Maintenance therapy
AML
Acute Myeloid Leukemia
Oral Azacitidine
Best supportive care
Complete remission
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 472
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Key Inclusion Criteria:

1. Male or female participants ≥ 55 years of age
2. Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
3. 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)
4. 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:

1. 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;
2. Participants who have signed the informed consent for the EP of the study;
3. Participants who do not meet any of the criteria for study discontinuation

Key Exclusion Criteria:

1. 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
2. Prior bone marrow or stem cell transplantation
3. Have achieved CR/CRi following therapy with hypomethylating agents
4. Diagnosis of malignant disease within the previous 12 months
5. Proven central nervous system (CNS) leukemia

Primary outcomes:
measure: Kaplan-Meier (K-M) Estimate for Overall Survival (OS)
timeFrame: Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.
Secondary outcomes:
measure: Kaplan-Meier Estimate of Relapse Free Survival (RFS)
timeFrame: From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
measure: Kaplan-Meier Estimate of Time to Relapse
timeFrame: Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months
measure: Kaplan-Meier Estimates of Time to Discontinuation From Treatment
timeFrame: From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 (randomization) to the data cut off date of 15 July 2019; the median treatment duration was 11.6 months (range: 0.5 to 74.3 months) for the oral aza arm and 5.7 months (range: 0.7 to 68.5 months) for the placebo arm.
measure: Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline
timeFrame: Baseline to Cycle 2, Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1C3, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, C23D1, C24D1, C25D1 and continued on day 1 at each cycle through C33D1
measure: Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline
timeFrame: Baseline to Cycle 2, Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1C3, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, C23D1, C24D1, C25D1 and continued on day 1 at each cycle through C33D1
measure: Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the FACIT-Fatigue Scale From Baseline
timeFrame: Baseline to Cycle 2, Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1C3, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, C23D1, C24D1, C25D1 and continued on day 1 at each cycle through C33D1
measure: Percentage of Participants Experiencing a Clinically Meaningful Change (Improvement, No Change and Deterioration) in the EQ-5D-3L Scale From Baseline
timeFrame: Baseline to Cycle 2, Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1C3, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, C23D1, C24D1, C25D1 and continued on day 1 at each cycle through C33D1
measure: Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0)
timeFrame: From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
measure: Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale
timeFrame: From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months
measure: Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year
timeFrame: Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months
measure: Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year
timeFrame: Day 1 (randomization) to the date of the data cut off date of 15 July 2019; approximately 74 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, P.C.
state: Arizona
city: Burbank
country: United States
facility: Providence St Joseph Medical Center Cancer Center
state: California
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Fresno
country: United States
facility: University of California San Francisco Fresno Campus
state: California
city: Los Angeles
country: United States
facility: University of Southern California Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: Local Institution - 006
state: California
city: Orange
country: United States
facility: Local Institution - 050
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Southington
country: United States
facility: Local Institution - 010
state: Connecticut
city: Washington
country: United States
facility: George Washington University Cancer Center
state: District of Columbia
city: Gainesville
country: United States
facility: Local Institution - 046
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Local Institution - 044
state: Florida
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Niles
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 013
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Westwood
country: United States
facility: Local Institution - 003
state: Kansas
city: Louisville
country: United States
facility: Local Institution - 049
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 058
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution - 047
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution - 015
state: Massachusetts
city: Rochester
country: United States
facility: Local Institution - 037
state: Minnesota
city: Kansas City
country: United States
facility: Local Institution - 023
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Omaha
country: United States
facility: Local Institution - 057
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Local Institution - 009
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 002
state: New York
city: Rochester
country: United States
facility: Local Institution - 004
state: New York
city: Valhalla
country: United States
facility: Local Institution - 014
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 025
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 016
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest Oncology Hematology
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 011
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 007
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 041
state: Texas
city: Fort Sam Houston
country: United States
facility: Local Institution - 034
state: Texas
city: Houston
country: United States
facility: Local Institution - 001
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas - Loop
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 039
state: Texas
city: Richmond
country: United States
facility: Local Institution - 035
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Inst
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/ North Star Lodge
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital BMT Medical College of Wisconsin
state: Wisconsin
city: Wollongong
country: Australia
facility: Local Institution - 510
state: New South Wales
city: South Brisbane
country: Australia
facility: Local Institution - 509
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 508
state: South Australia
city: Bedford Park
country: Australia
facility: Local Institution - 511
state: South Australia
city: Woodville South
country: Australia
facility: Local Institution - 504
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution - 503
city: Hobart
country: Australia
facility: Local Institution - 502
city: Liverpool
country: Australia
facility: Local Institution - 507
city: Melbourne
country: Australia
facility: Local Institution - 500
city: Perth
country: Australia
facility: Local Institution - 505
city: Perth
country: Australia
facility: Local Institution - 512
city: St Leonards
country: Australia
facility: Local Institution - 506
city: Woolloongabba
country: Australia
facility: Local Institution - 501
city: Graz
country: Austria
facility: Local Institution - 271
city: Salzburg
country: Austria
facility: Local Institution - 270
city: Vienna
country: Austria
facility: Local Institution - 274
city: Vienna
country: Austria
facility: Local Institution - 273
city: Wien
country: Austria
facility: Local Institution - 272
city: Brugge
country: Belgium
facility: Local Institution - 300
city: Charleroi
country: Belgium
facility: Local Institution - 301
city: Mons
country: Belgium
facility: Local Institution - 302
city: Curitiba
country: Brazil
facility: Local Institution - 233
state: Paraná
city: Porto Alegre
country: Brazil
facility: Local Institution - 231
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 232
city: Sao Paulo
country: Brazil
facility: Local Institution - 230
city: São Paulo
country: Brazil
facility: Local Institution - 234
city: Edmonton
country: Canada
facility: Local Institution - 605
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution - 600
state: Manitoba
city: Saint John
country: Canada
facility: Local Institution - 601
state: New Brunswick
city: St John's
country: Canada
facility: Local Institution - 603
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution - 604
state: Nova Scotia
city: Toronto
country: Canada
facility: Local Institution - 607
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 608
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 602
state: Quebec
city: Brno
country: Czechia
facility: Local Institution - 320
state: Jihomoravský Kraj
city: Praha
country: Czechia
facility: Local Institution - 321
city: Praha
country: Czechia
facility: Local Institution - 322
city: Helsinki
country: Finland
facility: Local Institution - 361
city: Tampere
country: Finland
facility: Local Institution - 362
city: Turku
country: Finland
facility: Local Institution - 360
city: Amiens
country: France
facility: Local Institution - 456
city: Argenteuil
country: France
facility: Local Institution - 465
city: Bobigny Cedex
country: France
facility: Local Institution - 457
city: Boulognes Sur Mer
country: France
facility: Local Institution - 462
city: Clamart Cedex
country: France
facility: Local Institution - 460
city: Creteil
country: France
facility: Local Institution - 452
city: Le Chesnay Cedex
country: France
facility: Local Institution - 458
city: Lille
country: France
facility: Local Institution - 453
city: Limoges Cedex
country: France
facility: Local Institution - 461
city: Lyon cedex
country: France
facility: Local Institution - 450
city: Paris Cedex 10
country: France
facility: Local Institution - 800
city: Paris
country: France
facility: Local Institution - 463
city: Paris
country: France
facility: Local Institution - 454
city: Pontoise
country: France
facility: Local Institution - 464
city: Rouen
country: France
facility: Local Institution - 455
city: Saint-Cloud
country: France
facility: Local Institution - 459
city: Villejuif CEDEX
country: France
facility: Local Institution - 451
city: Dresden
country: Germany
facility: Local Institution - 400
state: Saxony
city: Berlin
country: Germany
facility: Local Institution - 413
city: Bonn
country: Germany
facility: Local Institution - 410
city: Düsseldorf
country: Germany
facility: Local Institution - 406
city: Erlangen
country: Germany
facility: Local Institution - 415
city: Frankfurt am Main
country: Germany
facility: Local Institution - 404
city: Goch
country: Germany
facility: Local Institution - 412
city: Hannover
country: Germany
facility: Local Institution - 405
city: Heilbronn
country: Germany
facility: Local Institution - 408
city: Jena
country: Germany
facility: Local Institution - 414
city: Keil
country: Germany
facility: Local Institution - 403
city: Mannheim
country: Germany
facility: Local Institution - 402
city: Muenchen
country: Germany
facility: Local Institution - 409
city: München
country: Germany
facility: Local Institution - 411
city: Oldenburg
country: Germany
facility: Local Institution - 407
city: Schweiler
country: Germany
facility: Local Institution - 416
city: Ulm
country: Germany
facility: Local Institution - 401
city: Dublin
country: Ireland
facility: Local Institution - 950
city: Galway
country: Ireland
facility: Local Institution - 951
city: Beer Sheva
country: Israel
facility: Local Institution - 381
city: Haifa
country: Israel
facility: Local Institution - 380
city: Jerusalem
country: Israel
facility: Local Institution - 383
city: Petach Tikva
country: Israel
facility: Local Institution - 382
city: Alessandria
country: Italy
facility: Local Institution - 701
city: Bari
country: Italy
facility: Local Institution - 721
city: Bologna
country: Italy
facility: Local Institution - 720
city: Cagliari
country: Italy
facility: Local Institution - 710
city: Cremona
country: Italy
facility: Local Institution - 702
city: Firenze
country: Italy
facility: Local Institution - 708
city: Genova
country: Italy
facility: Local Institution - 712
city: Lecce
country: Italy
facility: Local Institution - 716
city: Milano
country: Italy
facility: Local Institution - 726
city: Milan
country: Italy
facility: Local Institution - 706
city: Monza
country: Italy
facility: Local Institution - 704
city: Naples
country: Italy
facility: Local Institution - 717
city: Naples
country: Italy
facility: Local Institution - 725
city: Orbassano (TO)
country: Italy
facility: Local Institution - 705
city: Palermo
country: Italy
facility: Local Institution - 703
city: Palermo
country: Italy
facility: Local Institution - 719
city: Pesaro
country: Italy
facility: Local Institution - 724
city: Reggio Calabria
country: Italy
facility: Local Institution - 700
city: Roma
country: Italy
facility: Local Institution - 709
city: Roma
country: Italy
facility: Local Institution - 714
city: Roma
country: Italy
facility: Local Institution - 723
city: Rome
country: Italy
facility: Local Institution - 722
city: Torino
country: Italy
facility: Local Institution - 715
city: Torino
country: Italy
facility: Local Institution - 718
city: Udine
country: Italy
facility: Local Institution - 711
city: Varese
country: Italy
facility: Local Institution - 707
city: Busan
country: Korea, Republic of
facility: Local Institution - 535
city: Daegu
country: Korea, Republic of
facility: Local Institution - 533
city: Seoul
country: Korea, Republic of
facility: Local Institution - 536
city: Seoul
country: Korea, Republic of
facility: Local Institution - 530
city: Seoul
country: Korea, Republic of
facility: Local Institution - 531
city: Seoul
country: Korea, Republic of
facility: Local Institution - 532
city: Klaipeda
country: Lithuania
facility: Local Institution - 750
city: Huixquilucan de Degollado
country: Mexico
facility: Local Institution - 252
city: Mexico
country: Mexico
facility: Local Institution - 251
city: Monterrey
country: Mexico
facility: Local Institution - 250
city: Bydgoszcz
country: Poland
facility: Local Institution - 824
city: Gdansk
country: Poland
facility: Local Institution - 820
city: Lodz
country: Poland
facility: Local Institution - 822
city: Warsaw
country: Poland
facility: Local Institution - 821
city: Wroclaw
country: Poland
facility: Local Institution - 823
city: Coimbra
country: Portugal
facility: Local Institution - 841
city: Lisboa
country: Portugal
facility: Local Institution - 840
city: Lisboa
country: Portugal
facility: Local Institution - 843
city: Porto
country: Portugal
facility: Local Institution - 842
city: Porto
country: Portugal
facility: Local Institution - 844
city: Moscow
country: Russian Federation
facility: Local Institution - 971
city: Nizhniy Novgorod
country: Russian Federation
facility: Local Institution - 970
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 972
city: St Petersburg
country: Russian Federation
facility: Local Institution - 973
city: Palma de Mallorca
country: Spain
facility: Local Institution - 872
state: Baleares
city: Badalona (Barcelona)
country: Spain
facility: Local Institution - 869
city: Barcelona
country: Spain
facility: Local Institution - 871
city: Barcelona
country: Spain
facility: Local Institution - 870
city: Caceres
country: Spain
facility: Local Institution - 873
city: Cordoba
country: Spain
facility: Local Institution - 863
city: La Coruna
country: Spain
facility: Local Institution - 867
city: Madrid
country: Spain
facility: Local Institution - 868
city: Madrid
country: Spain
facility: Local Institution - 866
city: Madrid
country: Spain
facility: Local Institution - 865
city: Oviedo
country: Spain
facility: Local Institution - 864
city: Salamanca
country: Spain
facility: Local Institution - 861
city: Sevilla
country: Spain
facility: Local Institution - 862
city: Valencia
country: Spain
facility: Local Institution - 860
city: Beitou District, Taipei City
country: Taiwan
facility: Local Institution - 599
city: Niaosong District Kaohsiung City
country: Taiwan
facility: Local Institution - 595
city: Taichung, Northern Dist.
country: Taiwan
facility: Local Institution - 596
city: Tainan, Taiana
country: Taiwan
facility: Local Institution - 597
city: Taipei, Zhongzheng Dist.
country: Taiwan
facility: Local Institution - 598
city: Ankara
country: Turkey
facility: Local Institution - 653
city: Ankara
country: Turkey
facility: Local Institution - 650
city: Istanbul
country: Turkey
facility: Local Institution - 651
city: Samsun
country: Turkey
facility: Local Institution - 652
city: Nottingham
country: United Kingdom
facility: Local Institution - 904
state: Nottinghamshire
city: Boston
country: United Kingdom
facility: Local Institution - 907
city: Brighton East Sussex
country: United Kingdom
facility: Local Institution - 903
city: Canterbury Kent
country: United Kingdom
facility: Local Institution - 902
city: London
country: United Kingdom
facility: Local Institution - 905
city: London
country: United Kingdom
facility: Local Institution - 901
city: London
country: United Kingdom
facility: Local Institution - 908
city: Maidstone
country: United Kingdom
facility: Local Institution - 909
city: Manchester
country: United Kingdom
facility: Local Institution - 900
city: Romford, Essex
country: United Kingdom
facility: Local Institution - 906
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.
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