COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Luspatercept
|
Drug: Luspatercept
Specified dose on specified days
Other Names:
|
Active Comparator: Epoetin alfa
|
Drug: Epoetin alfa
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL [Week 1 through Week 24]
Secondary Outcome Measures
- RBC-TI for 24 weeks [Week 1 through Week 24]
- Mean hemoglobin change over 24 weeks [Week 1 through Week 24]
- Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) [Week 1 through Week 24]
- Time to HI-E [Week 1 through Week 24]
- RBC-TI for ≥ 12 weeks (84 days) [Week 1 through Week 24]
- Duration of RBC-TI ≥ 12 weeks (84 days) [Week 1 through End of Treatment (EOT), up to approximately 60 months]
- Time to RBC-TI ≥ 12 weeks (84 days) [Week 1 through Week 24]
- Time to first red blood cell (RBC) transfusion [Week 1 through EOT, up to approximately 60 months]
- RBC transfusion burden on treatment [Week 1 through Week 24]
- RBC-TI for ≥ 56 days (8 weeks) [Week 1 through Week 24]
- RBC-TI for a consecutive 24-week period [Week 1 through Week 48]
- The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [Screening through Week 24]
- The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [Screening through Week 24]
- Number of participants with Adverse Events (AEs) [Week 1 through 42 days post last dose]
- Pharmacokinetic - area under the concentration-time curve (AUC) [Randomization through 1-year post first dose]
- Pharmacokinetic - maximum plasma concentration of drug (Cmax) [Randomization through 1-year post first dose]
- Frequency of antidrug antibodies (ADA) [Randomization through 1-year post first dose]
- Number of participants progressing to acute myeloid leukemia (AML) [Randomization through up to 60 months]
- Percentage of participants progressing to AML [Randomization through up to 60 months]
- Time to AML progression [Randomization through up to 60 months]
- Overall survival [Randomization through up to 60 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
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Endogenous serum erythropoietin (sEPO) level of < 500 U/L
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Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
-
Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
Exclusion Criteria:
-
Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
-
Known history of diagnosis of Acute myeloid leukemia (AML)
-
Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alabama Oncology - Grandview Cancer Center | Birmingham | Alabama | United States | 35243 |
2 | Alta Bates Summit Medical Center | Berkeley | California | United States | 94704 |
3 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
4 | Innovative Clinical Research Institute | Whittier | California | United States | 90603 |
5 | Innovative Clinical Research Institute | Whittier | California | United States | 90603 |
6 | Yale Cancer Center | New Haven | Connecticut | United States | 06520 |
7 | National Association of Veterans Research and Education Foundations NAVREF | Washington | District of Columbia | United States | 20422 |
8 | Florida Cancer Institute | Hudson | Florida | United States | 34667 |
9 | Florida Cancer Specialists North Region Sarah Cannon Research | Saint Petersburg | Florida | United States | 33705 |
10 | SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | United States | 32308 |
11 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
12 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
13 | Florida Cancer Specialists | West Palm Beach | Florida | United States | 33401 |
14 | Northwest Georgia Oncology Centers, PC | Austell | Georgia | United States | 30106 |
15 | Norton Healthcare | Louisville | Kentucky | United States | 40202 |
16 | Western Kentucky Hematology and Oncology Group | Paducah | Kentucky | United States | 42003 |
17 | Center For Cancer and Blood Disorders | Bethesda | Maryland | United States | 20817 |
18 | Center For Cancer And Blood Disorders | Bethesda | Maryland | United States | 20817 |
19 | HCA Midwest Health | Kansas City | Missouri | United States | 64132 |
20 | Astera Cancer Care East Brunswick | East Brunswick | New Jersey | United States | 08816 |
21 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
22 | East Carolina University | Greenville | North Carolina | United States | 27858-4354 |
23 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
24 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
25 | Univ of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
26 | Carolina Blood and Cancer Care | Rock Hill | South Carolina | United States | 29732 |
27 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
28 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
29 | UT Southwestern Simmons Cancer Center | Dallas | Texas | United States | 75390 |
30 | University of Texas- MD Anderson | Houston | Texas | United States | 77030 |
31 | University of Texas- MD Anderson | Houston | Texas | United States | 77030 |
32 | Utah Cancer Specialists - South Salt Lake | Salt Lake City | Utah | United States | 84106 |
33 | University of Virginia Health System | Charlottesville | Virginia | United States | 22903 |
34 | Peninsula Cancer Institute | Chesapeake | Virginia | United States | 23320 |
35 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
36 | Border Medical Oncology - Albury Wodonga Regional Cancer Centre | Albury | New South Wales | Australia | 2640 |
37 | Blacktown Hospital | Blacktown | New South Wales | Australia | 2148 |
38 | Local Institution - 213 | Blacktown | New South Wales | Australia | 2148 |
39 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
40 | Local Institution - 200 | Concord | New South Wales | Australia | 2139 |
41 | Local Institution - 215 | Kogarah | New South Wales | Australia | 2217 |
42 | St George Hospital | Kogarah | New South Wales | Australia | 2217 |
43 | Shoalhaven Cancer Care Centre | Nowra | New South Wales | Australia | 2541 |
44 | Local Institution - 210 | Waratah | New South Wales | Australia | 2298 |
45 | Newcastle Calvary Mater Hospital | Waratah | New South Wales | Australia | 2298 |
46 | Wollongong Hospital | Wollongong | New South Wales | Australia | 2500 |
47 | Icon Cancer Foundation | Auchenflower | Queensland | Australia | 4066 |
48 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
49 | Local Institution - 204 | Clayton | Victoria | Australia | 3168 |
50 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
51 | Cabrini Hospital | Malvern | Victoria | Australia | 3144 |
52 | Local Institution - 203 | Malvern | Victoria | Australia | 3144 |
53 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
54 | Perth Blood Institute | West Perth | Western Australia | Australia | 6005 |
55 | Local Institution - 212 | Randwick | Australia | 2031 | |
56 | The Prince of Wales Hospital | Randwick | Australia | 2031 | |
57 | Elisabethinen Hospital Linz | Linz | Austria | 4020 | |
58 | Medizinische Universitat Wien | Vienna | Austria | 1090 | |
59 | ZNA Middelheim | Antwerpen | Belgium | 2020 | |
60 | Algemeen Ziekenhuis Klina | Brasschaat | Belgium | 2930 | |
61 | Local Institution - 471 | Brasschaat | Belgium | 2930 | |
62 | Cliniques Universitaires St-Luc | Brussels | Belgium | 1200 | |
63 | Grand Hopital de Charleroi | Charleroi | Belgium | 6000 | |
64 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
65 | UZ Gasthuisberg | Leuven | Belgium | 3000 | |
66 | H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat | Roeselare | Belgium | 8800 | |
67 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
68 | University of Alberta | Edmonton | Alberta | Canada | T6G 2B7 |
69 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
70 | Local Institution - 142 | Hamilton | Ontario | Canada | L8V 5C2 |
71 | Ottawa General Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
72 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
73 | Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal | Montreal | Quebec | Canada | H1T 2M4 |
74 | Sir Mortimer B. Davis - Jewish Genl | Montreal | Quebec | Canada | H3T 1E2 |
75 | Saskatoon Cancer Center | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
76 | Centre Hospitalier Universitaire de Sherbrooke CHUS | Sherbrooke | Canada | J1H 5N4 | |
77 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
78 | Local Institution - 560 | Hradec Kralove | Czechia | 500 05 | |
79 | Fakultni Nemocnice Ostrava | Ostrava-Poruba | Czechia | 708 52 | |
80 | Local Institution - 564 | Ostrava-Poruba | Czechia | 708 52 | |
81 | Fakultni nemocnice Kralovske Vinohrady | Prague 10 | Czechia | 100 34 | |
82 | Local Institution - 562 | Praha 2 | Czechia | 128 08 | |
83 | Vseobecna Fakultni Nemocnice v Praze | Praha 2 | Czechia | 128 08 | |
84 | Ustav hematologie a krevni transfuze | Praha | Czechia | 128 20 | |
85 | CHU Angers | Angers | France | 49000 | |
86 | Local Institution - 317 | Angers | France | 49000 | |
87 | Centre Hospitalier de la cote basque | Bayonne | France | 64109 | |
88 | CHU de Caen | Caen Cedex 9 | France | 14033 | |
89 | Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon | La Tronche | France | 38700 | |
90 | Centre Hospitalier Le Mans | Le Mans | France | 72037 | |
91 | CHRU de Lille France | Lille | France | 59037 | |
92 | Local Institution - 309 | Lille | France | 59037 | |
93 | CHU Limoges | Limoges Cedex | France | 87042 | |
94 | Hotel Dieu CHU Nantes | Nantes Cedex 01 | France | 44093 | |
95 | CHU Nice Hopital de L'Archet 2 | Nice Cedex 3 | France | 06200 | |
96 | Local Institution - 301 | Nice Cedex 3 | France | 06200 | |
97 | Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis | Paris | France | 75010 | |
98 | Local Institution - 302 | Paris | France | 75010 | |
99 | Cochin, Hôpital | Paris | France | 75014 | |
100 | CHU Bordeaux | Pessac | France | 33604 | |
101 | Local Institution - 308 | Pessac | France | 33604 | |
102 | Centre Hospitalier Lyon Sud | Pierre Bénite | France | 69495 | |
103 | CHU de Poitiers | Poitiers | France | 86021 | |
104 | Local Institution - 316 | Poitiers | France | 86021 | |
105 | Institut de Cancérologie Strasbourg Europe | Strasbourg | France | 67033 | |
106 | CHU Purpan | Toulouse | France | 31059 | |
107 | CHRU Hopital BretonneauOnco-hematologie | Tours cedex | France | 37044 | |
108 | CHU de Nancy-Hopital Brabois Adulte | Vandoeuvre les Nancy | France | 54511 | |
109 | Stauferklinikum Schwab. Gmund | Baden-Warttemberg | Germany | 73557 | |
110 | Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim | Berlin | Germany | 14195 | |
111 | Local Institution - 426 | Dresden | Germany | 01307 | |
112 | Universitaetsklinikum Carl Gustav Carus | Dresden | Germany | 01307 | |
113 | St. Johannes Krankenhaus Duisburg | Duisburg | Germany | 47166 | |
114 | Local Institution - 420 | Dusseldorf | Germany | 40479 | |
115 | Marien Hospital | Dusseldorf | Germany | 40479 | |
116 | OncoResearch Lerchenfeld GmbH | Hamburg | Germany | 22081 | |
117 | Universitatsklinikum Schleswig-Holstein | Keil | Germany | 24105 | |
118 | Praxis fuer Haematologie und Onkologie Koblenz | Koblenz | Germany | 56068 | |
119 | Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie | Köln | Germany | 50677 | |
120 | Local Institution - 430 | Leipzig | Germany | 04103 | |
121 | Universitatsklinikum Leipzig | Leipzig | Germany | 04103 | |
122 | Universitaetsklinikum Mannheim | Mannheim | Germany | 68167 | |
123 | Klinikum rechts der Isar der Technischen Universitaet Muenchen | Munchen | Germany | 81675 | |
124 | Local Institution - 421 | Munchen | Germany | 81675 | |
125 | University Hospital of Ulm | Ulm | Germany | 89081 | |
126 | Klinkum der Stadt Villingen-Schwenningen GmbH | Villingen-Schwenningen | Germany | 78052 | |
127 | Rems-Murr-Kliniken | Winnenden | Germany | 71364 | |
128 | Hamatologisch-onkologische Praxis | Würzburg | Germany | 97070 | |
129 | Local Institution - 396 | Alexandroupolis | Greece | 08100 | |
130 | University Hospital of Alexandroupolis | Alexandroupolis | Greece | 08100 | |
131 | Evangelismos General Hospital of Athens | Athens | Greece | 10676 | |
132 | Laiko General Hospital of Athens | Athens | Greece | 11 527 | |
133 | Laiko General Hospital of Athens | Athens | Greece | 115 27 | |
134 | Local Institution - 391 | Athens | Greece | 115 27 | |
135 | Attikon university General Hospital | Athens | Greece | 12464 | |
136 | Local Institution - 392 | Athens | Greece | 12464 | |
137 | General Hospital of Athens - George Gennimatas | Athina | Greece | 115 27 | |
138 | Local Institution - 395 | Athina | Greece | 115 27 | |
139 | University General Hospital of Heraklion | Heraklion | Greece | 711 10 | |
140 | Local Institution - 398 | Patras | Greece | 26500 | |
141 | University of Patras | Patras | Greece | 26500 | |
142 | University General Hospital of Patras | Rio Patras | Greece | 26500 | |
143 | AHEPA University General Hospital of Thessaloniki | Thessaloniki | Greece | 546 36 | |
144 | Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | Greece | 57010 | |
145 | Semmelweis Egyetem | Budapest | Hungary | 1083 | |
146 | Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet | Budapest | Hungary | 1096 | |
147 | Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum | Debrecen | Hungary | 4032 | |
148 | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar | Hungary | 7400 | |
149 | Local Institution - 536 | Nyiregyhaza | Hungary | 4400 | |
150 | Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház | Nyiregyhaza | Hungary | 4400 | |
151 | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | Hungary | 6720 | |
152 | Carmel Medical Center | Haifa | Israel | 34362 | |
153 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
154 | Hadassah Medical Center | Jerusalem | Israel | 91120 | |
155 | Meir Medical Center | Kfar-Saba | Israel | 44281 | |
156 | Galilee Medical Center | Nahariya | Israel | 22100 | |
157 | Local Institution - 382 | Tel Aviv | Israel | 64239 | |
158 | Tel Aviv Sourasky Medical Center Department of Hematology | Tel Aviv | Israel | 64239 | |
159 | Shamir Medical Center - Assaf Harofeh | Zerifin | Israel | 70300 | |
160 | Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M | Bologna | Italy | 40138 | |
161 | Azienda Ospedaliera Universitaria Careggi | Firenze | Italy | 50134 | |
162 | Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) | Meldola | Italy | 47014 | |
163 | A.O. Ospedale Ca Granda - Niguarda | Milano | Italy | 20162 | |
164 | Local Institution - 321 | Milano | Italy | 20162 | |
165 | Azienda Ospedaliero - Universitaria San Luigi Gonzaga | Orbassano | Italy | 10043 | |
166 | Hospital of Di Padova | Padova | Italy | 35128 | |
167 | Azienda Ospedaliera Bianchi Melacrino Morelli | Reggio Di Calabria | Italy | 89124 | |
168 | Local Institution - 326 | Reggio Di Calabria | Italy | 89124 | |
169 | Fondazione PTV Policlinico Tor Vergata | Roma | Italy | 00133 | |
170 | Local Institution - 328 | Roma | Italy | 00133 | |
171 | Azienda Ospedaliera Sant Andrea | Roma | Italy | 00189 | |
172 | La Sapienza, University of Rome | Rome | Italy | 00161 | |
173 | Istituto Clinico Humanitas | Rozzano | Italy | 20089 | |
174 | Local Institution - 323 | Rozzano | Italy | 20089 | |
175 | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine | Udine | Italy | 33100 | |
176 | Hyogo Prefectural Amagasaki General Medical Center | Amagasaki-Shi | Japan | 660-0892 | |
177 | Fujisawa City Hospital | Fujisawa-Shi | Japan | 251-0052 | |
178 | National Hospital Organization Kyushu Medical Center | Fukuoka | Japan | 810-8563 | |
179 | Hitachi General Hospital | Hitachi, Ibaraki | Japan | 317-0077 | |
180 | Local Institution - 237 | Hitachi, Ibaraki | Japan | 317-0077 | |
181 | Kameda General Hospital | Kamogawa | Japan | 296-8602 | |
182 | JCHO Kyushu Hospital | Kitakyushu-Shi | Japan | 806-0034 | |
183 | Matsuyama Red Cross Hospital | Matsuyama | Japan | 790-8524 | |
184 | Nagaoka Red Cross Hospital | Nagaoka-Shi | Japan | 940-2108 | |
185 | The Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki | Japan | 852-8511 | |
186 | National Hospital Organization - Nagoya Medical Center | Nagoya-shi | Japan | 460-0001 | |
187 | Ogaki Municipal Hospital | Ogaki | Japan | 503-8502 | |
188 | Okayama City General Medical Center | Okayama | Japan | 700-8557 | |
189 | Kindai University Hospital | Osaka-Sayama | Japan | 589-8511 | |
190 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
191 | Kitasato University Hospital | Sagamihara | Japan | 252-0375 | |
192 | Aiiku Hospital | Sapporo-shi | Japan | 064-0804 | |
193 | Tohoku University Hospital | Sendai | Japan | 980-8574 | |
194 | Japan Red Cross Medical Center | Shibuya-ku | Japan | 150-8935 | |
195 | Dokkyo Medical University Hospital | Shimotsuga-gun | Japan | 321-0293 | |
196 | NTT Medical Center Tokyo | Shinagawa-ku, Tokyo | Japan | 141-8625 | |
197 | Local Institution - 251 | Busan | Korea, Republic of | 49241 | |
198 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
199 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 700-721 | |
200 | Chonnam National University Hwasun Hospital | Hwasun-Gun | Korea, Republic of | 58128 | |
201 | Local Institution - 253 | Seongnam-si | Korea, Republic of | 13620 | |
202 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13620 | |
203 | Local Institution - 256 | Seoul | Korea, Republic of | 06591 | |
204 | The Catholic University of Korea Seoul - Saint Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
205 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
206 | Seoul National University Hospital | Seoul | Korea, Republic of | 3080 | |
207 | Asan Medical Center | Seoul | Korea, Republic of | 5505 | |
208 | Local Institution - 254 | Seoul | Korea, Republic of | 5505 | |
209 | Hospital of Lithuanian University Health and Sciences | Kaunas | Lithuania | LT-50009 | |
210 | Local Institution - 541 | Vilnius | Lithuania | LT-08661 | |
211 | Vilnius University Hospital Santariskiu Klinikos | Vilnius | Lithuania | LT-08661 | |
212 | VU University Medical Center | Amsterdam | Netherlands | 1081 HV | |
213 | HagaZiekenhuis | Den Haag | Netherlands | 2545 CH | |
214 | Radboudumc | Nijmegen | Netherlands | 6525 GA | |
215 | Erasmus Universitair Medisch Centrum | Rotterdam | Netherlands | 3015 CE | |
216 | Zuyderland Medisch Centrum | Sittard-Geleen | Netherlands | 6162 BG | |
217 | Local Institution - 570 | Lodz | Lódzkie | Poland | 93-513 |
218 | Local Institution - 575 | Gdansk | Poland | 80-952 | |
219 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
220 | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Poland | 93-513 | |
221 | Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku | Lubin | Poland | 20-081 | |
222 | Local Institution - 576 | Poznan | Poland | 60-569 | |
223 | Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | Poland | 60-569 | |
224 | Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie | Rzwszow | Poland | 35-055 | |
225 | Wojewodzki Szpital Specjalistyczny im Korczaka w Supsku | Slupsk | Poland | 76-200 | |
226 | Local Institution - 578 | Walbrzych | Poland | 58-309 | |
227 | Specjalistyczny Szpital im. dra Alfreda Sokolowskiego | Walbrzych | Poland | 58-309 | |
228 | Wojskowy Instytut Medyczny | Warsaw | Poland | 04-141 | |
229 | Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | Poland | 50-367 | |
230 | Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych | Wroclaw | Poland | 50-556 | |
231 | Local Institution - 571 | Wroclaw | Poland | 50-556 | |
232 | Hospital José Joaquim Fernandes | Beja | Portugal | 7801-849 | |
233 | Local Institution - 373 | Beja | Portugal | 7801-849 | |
234 | Hospital de Braga | Braga | Portugal | 4710-243 | |
235 | Instituto Portugues de Oncologia de Lisboa, Francisco Gentil | Lisboa | Portugal | 1099-023 | |
236 | Ipo Instituto Portugues De Oncologia Porto | Porto | Portugal | 4200-072 | |
237 | Centro Hospitalar de Setubal EPE | Setubal | Portugal | 2910-446 | |
238 | Kaluga Regional Hospital | Kaluga | Russian Federation | 248007 | |
239 | Kaluga Regional Hospital | Kaluga | Russian Federation | 248007 | |
240 | Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec | Kirov | Russian Federation | 610027 | |
241 | Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec | Kirov | Russian Federation | 610027 | |
242 | Krasnoyarsk Regional Clinical Hospital | Krasnoyarsk | Russian Federation | 660022 | |
243 | Krasnoyarsk Regional Clinical Hospital | Krasnoyarsk | Russian Federation | 660022 | |
244 | Moscow Clinical Scientific Center | Moscow | Russian Federation | 111123 | |
245 | Moscow Clinical Scientific Center | Moscow | Russian Federation | 111123 | |
246 | City Clinical Hospital 52 | Moscow | Russian Federation | 123182 | |
247 | Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin | Moscow | Russian Federation | 125284 | |
248 | Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin | Moscow | Russian Federation | 125284 | |
249 | City Clinical Hospital 40 | Moscow | Russian Federation | 129301 | |
250 | Saratov State Medical University | Saratov | Russian Federation | 410012 | |
251 | Saratov State Medical University | Saratov | Russian Federation | 410012 | |
252 | Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov | St Petersburg | Russian Federation | 197341 | |
253 | Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov | St Petersburg | Russian Federation | 197341 | |
254 | First Pavlov State Medical University of St. Petersburg | St. Petersburg | Russian Federation | 197022 | |
255 | First Pavlov State Medical University of St. Petersburg | St. Petersburg | Russian Federation | 197022 | |
256 | Tula Regional Oncology Center | Tula | Russian Federation | 300053 | |
257 | Tula Regional Oncology Center | Tula | Russian Federation | 300053 | |
258 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
259 | Instituto Catalan de Oncologia-Hospital Duran i Reynals | Barcelona | Spain | 08908 | |
260 | Hospital Virgenes de las Nieves | Granada | Spain | 18014 | |
261 | Hospital General Universitario Gregorio Maranon | Madrid | Spain | 28007 | |
262 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
263 | Hospital Universitario Virgen De La Victoria | Malaga | Spain | 29010 | |
264 | Hospital General Universitario Morales Meseguer | Murcia | Spain | 30008 | |
265 | C. H. de Orense | Ourense | Spain | 32005 | |
266 | Hospital Universitario Central de Asturias | Oviedo | Spain | 33011 | |
267 | Hospital Son Espases | Palma de Mallorca | Spain | 7120 | |
268 | Local Institution - 362 | Palma de Mallorca | Spain | 7120 | |
269 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 | |
270 | Hospital Universitario Virgen del Rocio | Seville | Spain | 41013 | |
271 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
272 | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | 46026 | |
273 | Sahlgrenska Universitetssjukhuset | Goteborg | Sweden | SE-413 45 | |
274 | Skanes Universitetssjukhus Lund | Lund | Sweden | SE-221 85 | |
275 | Karolinska Universitetssjukhuset - Huddinge | Stockholm | Sweden | SE-141 86 | |
276 | Inselspital Bern | Bern | Switzerland | 3010 | |
277 | Local Institution - 450 | Bern | Switzerland | 3010 | |
278 | Luzerner Kantonsspital | Luzern 16 | Switzerland | 6000 | |
279 | Kantonsspital Winterthur | Winterthur | Switzerland | 8400 | |
280 | Local Institution - 451 | Winterthur | Switzerland | 8400 | |
281 | Changhua Christian Hospital | Changhua City, Changhua | Taiwan | 500 | |
282 | Local Institution - 220 | Changhua City, Changhua | Taiwan | 500 | |
283 | Kaohsiung Chang Gung Memorial Hospital | Niaosong District Kaohsiung City | Taiwan | 83301 | |
284 | China Medical University Hospital | Taichung City | Taiwan | 40447 | |
285 | Local Institution - 223 | Taichung City | Taiwan | 40447 | |
286 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
287 | Local Institution - 221 | Taipei, Zhongzheng Dist. | Taiwan | 10002 | |
288 | National Taiwan University Hospital | Taipei, Zhongzheng Dist. | Taiwan | 10002 | |
289 | Ankara University Medical Faculty | Ankara | Turkey | 06100 | |
290 | Celal Bayar University Medical Faculty | Manisa | Turkey | 45030 | |
291 | Karadeniz Technical University Medical Faculty | Trabzon | Turkey | 61080 | |
292 | Cherkassy Regional Oncology Center | Cherkassy | Ukraine | 18009 | |
293 | Cherkassy Regional Oncology Center | Cherkassy | Ukraine | 18009 | |
294 | Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center | Dnipro | Ukraine | 49102 | |
295 | Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center | Dnipro | Ukraine | 49102 | |
296 | State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine | Kyiv | Ukraine | 3115 | |
297 | Institute of Blood Pathology and Transfusion Medicine of the UAMS | Lvov | Ukraine | 79044 | |
298 | Institute of Blood Pathology and Transfusion Medicine of the UAMS | Lvov | Ukraine | 79044 | |
299 | Mykolaiv Regional Clinical Hospital | Mykolaiv | Ukraine | 54058 | |
300 | Mykolaiv Regional Clinical Hospital | Mykolaiv | Ukraine | 54058 | |
301 | CI of TRC Ternopil University Hospital | Ternopil | Ukraine | 46002 | |
302 | CI of TRC Ternopil University Hospital | Ternopil | Ukraine | 46002 | |
303 | Aberdeen Royal Infirmary | Aberdeen | United Kingdom | AB25 2ZN | |
304 | Royal Bournemouth Hospital | Bournemouth | United Kingdom | BH7 7DW | |
305 | University of Oxford | Headington, Oxford | United Kingdom | OX3 7LE | |
306 | Lincoln County Hospital | Lincoln | United Kingdom | LN2 5QY | |
307 | Local Institution - 407 | Lincoln | United Kingdom | LN2 5QY | |
308 | Kings College Hospital | London | United Kingdom | SE5 9RS | |
309 | Hammersmith Hospital | London | United Kingdom | W12 0HS | |
310 | Christie Hospital NHS Trust | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Celgene
- Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ACE-536-MDS-002
- U1111-1218-1810
- 2017-003190-34