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.
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.
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
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There are 213 Locations for this study
Phoenix Arizona, 85016, United States
Burbank California, 91505, United States
Duarte California, 91010, United States
Fresno California, 93701, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Diego California, 92123, United States
Stanford California, 94305, United States
Whittier California, 90603, United States
Denver Colorado, 80218, United States
Southington Connecticut, 06489, United States
Washington District of Columbia, 20037, United States
Gainesville Florida, 32610, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46237, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02215, United States
Worcester Massachusetts, 01655, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64128, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08901, United States
Mineola New York, 11501, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Valhalla New York, 10595, United States
Durham North Carolina, 27705, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97227, United States
Lancaster Pennsylvania, 17604, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Fort Sam Houston Texas, 78234, United States
Houston Texas, 77030, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78229, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98104, United States
Yakima Washington, 98902, United States
Milwaukee Wisconsin, 53226, United States
Wollongong New South Wales, 2500, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, SA 50, Australia
Bedford Park South Australia, 5042, Australia
Woodville South South Australia, 5011, Australia
Heidelberg , 3084, Australia
Hobart , 7000, Australia
Liverpool , 2170, Australia
Melbourne , 3004, Australia
Perth , 6000, Australia
Perth , 6000, Australia
St Leonards , 2065, Australia
Woolloongabba , 4102, Australia
Graz , 73013, Austria
Salzburg , 5020, Austria
Vienna , 1130, Austria
Vienna , 1190, Austria
Wien , 1140, Austria
Brugge , 8000, Belgium
Charleroi , 6000, Belgium
Mons , 7000, Belgium
Curitiba Paraná, 81520, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , 05651, Brazil
São Paulo , 01308, Brazil
Edmonton Alberta, T6G 2, Canada
Winnipeg Manitoba, R3E O, Canada
Saint John New Brunswick, E2L 4, Canada
St John's Newfoundland and Labrador, A1B3V, Canada
Halifax Nova Scotia, B3H 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H4J 1, Canada
Brno Jihomoravský Kraj, 625 0, Czechia
Praha , 128 0, Czechia
Praha , 128 2, Czechia
Helsinki , 290, Finland
Tampere , 33521, Finland
Turku , 20521, Finland
Amiens , 80054, France
Argenteuil , 95100, France
Bobigny Cedex , 93009, France
Boulognes Sur Mer , 62200, France
Clamart Cedex , 92141, France
Creteil , 94010, France
Le Chesnay Cedex , 78157, France
Lille , 59037, France
Limoges Cedex , 87042, France
Lyon cedex , 69437, France
Paris Cedex 10 , 75475, France
Paris , 75015, France
Paris , 75475, France
Pontoise , 95301, France
Rouen , 76038, France
Saint-Cloud , 92210, France
Villejuif CEDEX , 94805, France
Dresden Saxony, 01307, Germany
Berlin , 12203, Germany
Bonn , 53127, Germany
Düsseldorf , 40225, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 65929, Germany
Goch , 47574, Germany
Hannover , 30625, Germany
Heilbronn , 74078, Germany
Jena , 07740, Germany
Keil , 24105, Germany
Mannheim , 68167, Germany
Muenchen , 80804, Germany
München , 81675, Germany
Oldenburg , 26133, Germany
Schweiler , 52249, Germany
Ulm , 89081, Germany
Dublin , 24, Ireland
Galway , ST46Q, Ireland
Beer Sheva , 84101, Israel
Haifa , 35254, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Alessandria , 15121, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Cagliari , O9126, Italy
Cremona , 26100, Italy
Firenze , 50129, Italy
Genova , 16132, Italy
Lecce , 73100, Italy
Milano , 20162, Italy
Milan , 20122, Italy
Monza , 20900, Italy
Naples , 80131, Italy
Naples , 80131, Italy
Orbassano (TO) , 10043, Italy
Palermo , 90146, Italy
Palermo , 90146, Italy
Pesaro , 31122, Italy
Reggio Calabria , 89100, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Roma , 00189, Italy
Rome , 133, Italy
Torino , 10126, Italy
Torino , 10126, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Busan , 49241, Korea, Republic of
Daegu , 700-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Klaipeda , 5809, Lithuania
Huixquilucan de Degollado , 52763, Mexico
Mexico , 14080, Mexico
Monterrey , 64460, Mexico
Bydgoszcz , 85-16, Poland
Gdansk , 80-21, Poland
Lodz , 93-51, Poland
Warsaw , 02-77, Poland
Wroclaw , 50-36, Poland
Coimbra , 4200-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1150-, Portugal
Porto , 4200-, Portugal
Porto , 4200, Portugal
Moscow , 12510, Russian Federation
Nizhniy Novgorod , 60300, Russian Federation
Saint Petersburg , 19602, Russian Federation
St Petersburg , 19734, Russian Federation
Palma de Mallorca Baleares, 07198, Spain
Badalona (Barcelona) , 8916, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Caceres , 10003, Spain
Cordoba , 14004, Spain
La Coruna , 15006, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Oviedo , 33006, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Beitou District, Taipei City , 11217, Taiwan
Niaosong District Kaohsiung City , 83301, Taiwan
Taichung, Northern Dist. , 404, Taiwan
Tainan, Taiana , 704, Taiwan
Taipei, Zhongzheng Dist. , 10002, Taiwan
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Istanbul , 34662, Turkey
Samsun , 55139, Turkey
Nottingham Nottinghamshire, NG5 1, United Kingdom
Boston , PE21 , United Kingdom
Brighton East Sussex , BN2 5, United Kingdom
Canterbury Kent , CT1 3, United Kingdom
London , NW1 2, United Kingdom
London , SE5 9, United Kingdom
London , W12 0, United Kingdom
Maidstone , ME16 , United Kingdom
Manchester , M20 4, United Kingdom
Romford, Essex , RM7 0, United Kingdom
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