Clinical trial NCT01566695: The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelodysplastic Syndrome
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Have a documented diagnosis of MDS
* Anemia that requires red blood cell transfusions
* Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Must agree to follow pregnancy precautions as required by protocol.
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted

Exclusion Criteria:

* Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
* Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide (for lenalidomide : unless the last dose received is \>= 8 weeks prior to inclusion into the study).
* Prior allogeneic or autologous stem cell transplant
* Eligible for allogenic or autologous stem cell transplant
* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
* Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)
* Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
* Ongoing medically significant adverse events from previous treatment, regardless of the time period
* Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS)
* Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis \[TNM\] clinical staging system is allowed)
* Significant active cardiac disease within the previous 6 months
* Uncontrolled systemic fungal, bacterial, or viral infection
* Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
* Abnormal coagulation parameters
* Abnormal liver function test results
* Abnormal kidney function test results
* Known or suspected hypersensitivity to azacitidine or mannitol
* Any significant medical condition, laboratory abnormality, or psychiatric illness

Primary outcomes:
measure: Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days
timeFrame: Each participant was assessed for at least 56 days or more; from the date of randomization of study drug up to the data cut-off date of 25 January 2019, approximately 5 months.
Secondary outcomes:
measure: Duration of RBC Transfusion Independence Among Participants Who Achieved RBC Transfusion Independence for at Least 56 Days
timeFrame: From the date of randomization of study drug up to the data cut-off date of 25 January 2019
measure: Time to RBC Transfusion Independence for at Least 56 Days Among Participants Who Achieved RBC Transfusion Independence for at Least 56 Days
timeFrame: From the date of randomization of study drug up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Duration of RBC Transfusion Reduction for Participants Who Achieved RBC Transfusion Reduction of at Least 4 Units of RBCs for at Least 8 Weeks
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants Who Achieved RBC Transfusion Independence for ≥ 84 Days
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Duration of RBC Transfusion Independence Among Participants Who Achieved RBC Transfusion Independence for at Least 84 Days
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Time to RBC Transfusion Independence for at Least 84 Days Among Participants Who Achieved RBC Transfusion Independence for at Least 84 Days
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants With an Erythroid Hematological Improvement (HI-E) Response According to 2006 IWG Criteria
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants With a Hematological Improvement Response in Platelets (HI-P) According to 2006 IWG Criteria
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants Who Achieved Platelet Transfusion Independence With a Duration of ≥ 8 Weeks (56 Days)
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Time to Platelet Transfusion Independence
timeFrame: From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Overall Survival (OS)
timeFrame: From randomization up to death from any cause; up to a maximum of approximately 10 years on study; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants With a Hematologic Response According to the 2006 IWG Criteria for MDS
timeFrame: Response was assessed every 3 cycles; up to the data cut-off date of 25 Jan 2019; median duration of exposure to oral azacitidine was 86.0 days and 119.0 days for placebo
measure: Percentage of Participants Who Progressed to Acute Myeloid Leukemia (AML)
timeFrame: From randomization of study drug to the end up to final data cut-off date of 25 January 2019; maximum follow-up time was 67.9 months for azacitidine and 64.8 months for placebo group
measure: Time to Progression to Acute Myeloid Leukemia (AML) Among Participants Who Progressed to AML
timeFrame: From randomization of study drug to progression of AML; up to a maximum of approximately 10 years on study; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Percentage of Participants With Significant Bleeding Events
timeFrame: From date of randomization until 28 days after the last dose of IP; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: From first dose of IP up to 28 days after the last dose of IP or until the last study visit; up to a maximum of approximately 6 months on study
measure: Mean Change From Baseline in the Physical Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Social Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Emotional Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Functional Well-Being Component of the FACT-An Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Anemia Subscale Within FACT-An Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Fatigue-Related Subscale Within the FACT-An Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Trial Outcome Index (FACT-An TOI) Summary Scale Within the FACT-An Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia-General (FACT-G) Summary Scale Within the FACT-An Instrument at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia-Total Score at Cycle 6
timeFrame: Baseline to Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Physical Well-Being Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Social Well-Being Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Emotional Well-Being Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Functional Well-Being Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Anemia Subscale Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Fatigue Related Symptoms Subscale Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Functional Assessment of Cancer Therapy-Anemia Trial Outcome Index Subscale Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Functional Assessment of Cancer Therapy-Anemia-General Subscale Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With a Clinically Meaningful Improvement (CMI) From Baseline in the Functional Assessment of Cancer Therapy Anemia-Total Score Domain Within the FACT-An Instrument at Cycle 6
timeFrame: Cycle 6 Day 1
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 2 Day 1 (C2D1)
timeFrame: From Baseline to Cycle 2 Day 1 (C2D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 3 Day 1 (C3D1)
timeFrame: From Baseline to Cycle 3 Day 1 (C3D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 4 Day 1 (C4D1)
timeFrame: From Baseline to Cycle 4 Day 1 (C4D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 5 Day 1 (C5D1)
timeFrame: From Baseline to Cycle 5 Day 1 (C5D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 6 Day 1 (C6 D1)
timeFrame: From Baseline to Cycle 6 Day 1 (C6 D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 7 Day 1 (C7D1)
timeFrame: From Baseline to Cycle 7 Day 1 (C7D1)
measure: Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - End of Treatment
timeFrame: From Baseline to End of Treatment
measure: Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level (EQ-5D-3L) Mobility Dimension Responses at Cycle 6
timeFrame: From Baseline to Cycle 6 Day 1
measure: Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level of Self-Care Dimension Responses at Cycle 6
timeFrame: From Baseline to Cycle 6 Day 1
measure: Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level Usual Activities Dimension Responses at Cycle 6
timeFrame: From Baseline to Cycle 6 Day 1
measure: Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Pain/Discomfort Dimension Responses at Cycle 6
timeFrame: From Baseline to Cycle 6 Day 1
measure: Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Anxiety/Depression Dimension Responses at Cycle 6
timeFrame: From Baseline to Cycle 6 Day 1
measure: Healthcare Resource Utilization (HRU): Number of Participants Who Were Hospitalized
timeFrame: From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo
measure: Healthcare Resource Utilization (HRU): Total Number of Days Hospitalized Due to Any Reason
timeFrame: From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo
measure: Healthcare Resource Utilization (HRU): Total Number of Days Hospitalized Per Total Patient-Years
timeFrame: From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology/Oncology Medical Group and Tower Cancer Research Found
state: California
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Escondido
country: United States
facility: California Cancer Associates for Research and Excellence cCARE
state: California
city: Greenbrae
country: United States
facility: Marin Oncology Associates
state: California
city: La Jolla
country: United States
facility: UCSD-Thornton Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California Norris Cancer Center
state: California
city: New Haven
country: United States
facility: Local Institution - 942
state: Connecticut
city: Orlando
country: United States
facility: University of Florida Health Cancer Center at Orlando Health
state: Florida
city: Albany
country: United States
facility: Phoebe Cancer Center of Phoebe Putney Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Robert H Lurie Comprehensive Cancer Center NW Univ
state: Illinois
city: Chicago
country: United States
facility: University Of Illinois At Chicago
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville, J.G. Brown Cancer Center
state: Kentucky
city: Metairie
country: United States
facility: Hematology And Oncology Specialists, Llc
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Worcester
country: United States
facility: UMASS Memorial Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates PLLC
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center University of Kansas Medical Center
state: Missouri
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Weill Cornell Medical College - New York - Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Greenville
country: United States
facility: Eastern Institute of Medical Sciences
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Local Institution - 917
state: Oregon
city: Philadelphia
country: United States
facility: Penn Medicine: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center Francis Street Medical Center
state: Texas
city: Houston
country: United States
facility: Local Institution - 900
state: Texas
city: Houston
country: United States
facility: Local Institution - 924
state: Texas
city: Houston
country: United States
facility: Millennium Physicians - Oncology
state: Texas
city: Richmond
country: United States
facility: VA Commonwealth University - Massey Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 904
state: Washington
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
city: Garran
country: Australia
facility: Local Institution - 137
state: Australian Capital Territory
city: Adelaide
country: Australia
facility: Local Institution - 129
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 134
state: Victoria
city: Frankston
country: Australia
facility: Local Institution - 132
state: Victoria
city: Camperdown
country: Australia
facility: Local Institution - 131
city: Epping, VIC
country: Australia
facility: Local Institution - 127
city: Fitzroy
country: Australia
facility: Local Institution - 133
city: Kogarah
country: Australia
facility: Local Institution - 135
city: Malvern
country: Australia
facility: Local Institution - 130
city: Milton, Brisbane
country: Australia
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city: Waratah
country: Australia
facility: Local Institution - 138
city: Woolloongabba
country: Australia
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city: Brasschaat
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city: Brugge
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city: Charleroi
country: Belgium
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city: Leuven
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city: Fortaleza
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state: Ceará
city: Curitiba
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state: Paraná
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state: Rio Grande Do Sul
city: Rio De Janeiro
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city: Sao Paulo
country: Brazil
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city: Edmonton
country: Canada
facility: Local Institution - 182
state: Alberta
city: Vancouver
country: Canada
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state: British Columbia
city: Barrie
country: Canada
facility: Local Institution - 183
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution - 180
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 179
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 176
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 181
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 177
state: Quebec
city: Brno
country: Czechia
facility: Local Institution - 226
state: Jihomoravský Kraj
city: Hradec Králové
country: Czechia
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city: Olomouc
country: Czechia
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city: Praha
country: Czechia
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city: Praha
country: Czechia
facility: Local Institution - 227
city: Aarhus
country: Denmark
facility: Local Institution - 253
city: Odense C
country: Denmark
facility: Local Institution - 252
city: Roskilde
country: Denmark
facility: Local Institution - 251
city: Helsinki
country: Finland
facility: Local Institution - 276
city: Turku
country: Finland
facility: Local Institution - 277
city: Lille
country: France
facility: Local Institution - 305
city: Marseille Cedex 9
country: France
facility: Local Institution - 304
city: Nantes
country: France
facility: Local Institution - 301
city: Paris
country: France
facility: Local Institution - 308
city: Pierre-Bénite Cedex
country: France
facility: Local Institution - 307
city: Rennes Cedex
country: France
facility: Local Institution - 302
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country: France
facility: Local Institution - 303
city: Strasbourg
country: France
facility: Local Institution - 306
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country: France
facility: Local Institution - 300
city: Tours
country: France
facility: Local Institution - 309
city: Dresden
country: Germany
facility: Local Institution - 350
city: Dresden
country: Germany
facility: Local Institution - 361
city: Duesseldorf
country: Germany
facility: Local Institution - 359
city: Dusseldorf
country: Germany
facility: Local Institution - 355
city: Hamburg
country: Germany
facility: Local Institution - 356
city: Keil
country: Germany
facility: Local Institution - 353
city: Leipzig
country: Germany
facility: Local Institution - 351
city: München
country: Germany
facility: Local Institution - 352
city: Tubingen
country: Germany
facility: Local Institution - 357
city: Ulm
country: Germany
facility: Local Institution - 360
city: Heraklion
country: Greece
facility: Local Institution - 853
state: Irakleio
city: Alexandroupolis
country: Greece
facility: Local Institution - 851
city: Athens
country: Greece
facility: Local Institution - 852
city: Athens
country: Greece
facility: Local Institution - 855
city: Athens
country: Greece
facility: Local Institution - 850
city: Patras
country: Greece
facility: Local Institution - 854
city: Tel-Aviv
country: Israel
facility: Local Institution - 452
state: Tel Aviv
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facility: Local Institution - 453
city: Petach Tikva
country: Israel
facility: Local Institution - 451
city: Tel Hashomer
country: Israel
facility: Local Institution - 454
city: Alessandria
country: Italy
facility: Local Institution - 482
city: Bari
country: Italy
facility: Local Institution - 492
city: Bologna
country: Italy
facility: Local Institution - 489
city: Cagliari
country: Italy
facility: Local Institution - 494
city: Firenze
country: Italy
facility: Local Institution - 486
city: Lecce
country: Italy
facility: Local Institution - 479
city: Milano
country: Italy
facility: Local Institution - 488
city: Milan
country: Italy
facility: Local Institution - 498
city: Novara
country: Italy
facility: Local Institution - 497
city: Palermo
country: Italy
facility: Local Institution - 480
city: Pavia
country: Italy
facility: Local Institution - 495
city: Pisa
country: Italy
facility: Local Institution - 496
city: Reggio Calabria
country: Italy
facility: Local Institution - 485
city: Rionero in Vulture
country: Italy
facility: Local Institution - 484
city: Roma
country: Italy
facility: Local Institution - 487
city: Roma
country: Italy
facility: Local Institution - 490
city: Roma
country: Italy
facility: Local Institution - 481
city: Terni
country: Italy
facility: Local Institution - 499
city: Torino
country: Italy
facility: Local Institution - 477
city: Torrette Di Ancona
country: Italy
facility: Local Institution - 493
city: Udine
country: Italy
facility: Local Institution - 478
city: Venezia - Mestre
country: Italy
facility: Local Institution - 476
city: Busan
country: Korea, Republic of
facility: Local Institution - 704
city: Daegu
country: Korea, Republic of
facility: Local Institution - 703
city: Seoul
country: Korea, Republic of
facility: Local Institution - 701
city: Seoul
country: Korea, Republic of
facility: Local Institution - 702
city: Seoul
country: Korea, Republic of
facility: Local Institution - 700
city: Huixquilucan de Degollado
country: Mexico
facility: Local Institution - 830
city: Monterrey
country: Mexico
facility: Local Institution - 828
city: Monterrey
country: Mexico
facility: Local Institution - 829
city: Tlalpan
country: Mexico
facility: Local Institution - 827
city: Amsterdam
country: Netherlands
facility: Local Institution - 528
city: Groningen
country: Netherlands
facility: Local Institution - 527
city: Nijmegen
country: Netherlands
facility: Local Institution - 526
city: Rotterdam
country: Netherlands
facility: Local Institution - 529
city: Førde
country: Norway
facility: Local Institution - 552
city: Oslo
country: Norway
facility: Local Institution - 551
city: Bydgoszcz
country: Poland
facility: Local Institution - 582
city: Gdansk
country: Poland
facility: Local Institution - 576
city: Krakow
country: Poland
facility: Local Institution - 579
city: Lodz
country: Poland
facility: Local Institution - 581
city: Torun
country: Poland
facility: Local Institution - 580
city: Warszawa
country: Poland
facility: Local Institution - 583
city: Warszawa
country: Poland
facility: Local Institution - 577
city: Wroclaw
country: Poland
facility: Local Institution - 578
city: Beja
country: Portugal
facility: Local Institution - 604
city: Coimbra
country: Portugal
facility: Local Institution - 600
city: Lisboa
country: Portugal
facility: Local Institution - 601
city: Lisboa
country: Portugal
facility: Local Institution - 603
city: Porto
country: Portugal
facility: Local Institution - 602
city: Badalona (Barcelona)
country: Spain
facility: Local Institution - 626
city: Barcelona
country: Spain
facility: Local Institution - 635
city: Barcelona
country: Spain
facility: Local Institution - 625
city: Granada
country: Spain
facility: Local Institution - 636
city: Madrid
country: Spain
facility: Local Institution - 629
city: Madrid
country: Spain
facility: Local Institution - 634
city: Madrid
country: Spain
facility: Local Institution - 631
city: Malaga
country: Spain
facility: Local Institution - 632
city: Oviedo
country: Spain
facility: Local Institution - 628
city: Salamanca
country: Spain
facility: Local Institution - 630
city: Seville
country: Spain
facility: Local Institution - 627
city: Vitoria-Gasteiz, Álava
country: Spain
facility: Local Institution - 633
city: Goeteborg
country: Sweden
facility: Local Institution - 653
city: Lund
country: Sweden
facility: Local Institution - 652
city: Stockholm
country: Sweden
facility: Local Institution - 651
city: Adana
country: Turkey
facility: Local Institution - 401
city: Antalya
country: Turkey
facility: Local Institution - 405
city: Istanbul
country: Turkey
facility: Local Institution - 403
city: Istanbul
country: Turkey
facility: Local Institution - 400
city: Mersin
country: Turkey
facility: Local Institution - 404
city: Trabzon
country: Turkey
facility: Local Institution - 402
city: Oxford
country: United Kingdom
facility: Local Institution - 685
state: Oxfordshire
city: Aberdeen
country: United Kingdom
facility: Local Institution - 687
city: Birmingham
country: United Kingdom
facility: Local Institution - 691
city: Bristol
country: United Kingdom
facility: Local Institution - 686
city: Cambridge
country: United Kingdom
facility: Local Institution - 689
city: Cardiff
country: United Kingdom
facility: Local Institution - 678
city: Harrow Middlesex
country: United Kingdom
facility: Local Institution - 688
city: Hull
country: United Kingdom
facility: Local Institution - 692
city: Leicester
country: United Kingdom
facility: Local Institution - 677
city: Liverpool
country: United Kingdom
facility: Local Institution - 683
city: London
country: United Kingdom
facility: Local Institution - 676
city: London
country: United Kingdom
facility: Local Institution - 684
city: Manchester
country: United Kingdom
facility: Local Institution - 679
city: Nottingham
country: United Kingdom
facility: Local Institution - 681
city: Sutton in Ashfield
country: United Kingdom
facility: Local Institution - 690
city: Wolverhampton
country: United Kingdom
facility: Local Institution - 680
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Garcia-Manero G, Almeida A, Giagounidis A, Platzbecker U, Garcia R, Voso MT, Larsen SR, Valcarcel D, Silverman LR, Skikne B, Santini V. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion-dependent anemia and thrombocytopenia. BMC Hematol. 2016 May 3;16:12. doi: 10.1186/s12878-016-0049-5. eCollection 2016.
citation: Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Oliva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.