Myelodysplastic Syndrome Clinical Trial

Radium-223 Dichloride Long-term Follow-up Program

Summary

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

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Full Description

This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).

The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial

Exclusion Criteria:

Not applicable to this follow up study

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 4

Estimated Enrollment:

800

Study ID:

NCT02312960

Recruitment Status:

Recruiting

Sponsor:

Bayer

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There are 149 Locations for this study

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Anchorage Alaska, 99503, United States

Tucson Arizona, 85704, United States

Plantation Florida, 33324, United States

Indianapolis Indiana, 46202, United States

Ashland Kentucky, 41101, United States

New Orleans Louisiana, 70112, United States

Shreveport Louisiana, 71103, United States

Baltimore Maryland, 21201, United States

Boston Massachusetts, 02114, United States

Detroit Michigan, 48201, United States

Omaha Nebraska, 68130, United States

Jamaica New York, 11432, United States

Syracuse New York, 13210, United States

Pittsburgh Pennsylvania, 15215, United States

Watertown South Dakota, 57201, United States

Seattle Washington, 98109, United States

Darlinghurst New South Wales, 2010, Australia

Westmead New South Wales, 2145, Australia

Adelaide South Australia, 5000, Australia

East Bentleigh Victoria, 3165, Australia

Fitzroy Victoria, 3065, Australia

Heidelberg Victoria, 3084, Australia

Anderlecht , 1070, Belgium

Edegem , 2650, Belgium

Kortrijk , 8500, Belgium

Leuven , 3000, Belgium

Belo Horizonte Minas Gerais, 30130, Brazil

Porto Alegre Rio Grande Do Sul, 90050, Brazil

Barretos Sao Paulo, 14784, Brazil

São Paulo Sao Paulo, 01246, Brazil

Toronto Ontario, M4N 3, Canada

Montreal Quebec, H2X 0, Canada

Santiago , 75009, Chile

Praha 2 , 128 0, Czechia

Helsinki , 00290, Finland

Kuopio , 70210, Finland

Tampere , FIN-3, Finland

Bordeaux Cedex , 33076, France

Nantes , 44805, France

NIMES cedex 9 , 30029, France

Poitiers , 86021, France

Saint Cloud , 92210, France

Toulouse Cedex 9 , 31059, France

Tours , 37044, France

Villejuif , 94805, France

Freiburg im Breisgau Baden-Württemberg, 79106, Germany

Tübingen Baden-Württemberg, 72076, Germany

Ulm Baden-Württemberg, 89091, Germany

Erlangen Bayern, 91054, Germany

München Bayern, 81377, Germany

München Bayern, 81675, Germany

Rostock Mecklenburg-Vorpommern, 18107, Germany

Aachen Nordrhein-Westfalen, 52074, Germany

Mainz Rheinland-Pfalz, 55131, Germany

Dresden Sachsen, 01307, Germany

Jena Thüringen, 07747, Germany

Berlin , 10719, Germany

Berlin , 12203, Germany

Bremen , 28277, Germany

Hamburg , 20246, Germany

Magdeburg , 39120, Germany

Chai Wan , , Hong Kong

Afula , 18341, Israel

Beer Sheva , 84101, Israel

Haifa , 31096, Israel

Jerusalem , 91120, Israel

Jerusalem , 93722, Israel

Kfar Saba , 44281, Israel

Petach Tikva , 49414, Israel

Ramat Gan , 52620, Israel

Tel Aviv , 64239, Israel

Zrifin , 70300, Israel

Bologna Emilia-Romagna, 40138, Italy

Forlì Cesena Emilia-Romagna, 47014, Italy

Modena Emilia-Romagna, 41124, Italy

Roma Lazio, 00161, Italy

Roma Lazio, 00189, Italy

Milano Lombardia, 20133, Italy

Milano Lombardia, 20141, Italy

Torino Piemonte, 10043, Italy

Cagliari Sardegna, 09125, Italy

Trento Trentino-Alto Adige, 38100, Italy

Matsuyama Ehime, 791-0, Japan

Sapporo Hokkaido, 003-0, Japan

Sapporo Hokkaido, 060-8, Japan

Kanazawa Ishikawa, 920-8, Japan

Yokohama Kanagawa, 236-0, Japan

Yokohama Kanagawa, 241-8, Japan

Sendai Miyagi, 980-8, Japan

Kurashiki Okayama, 701-0, Japan

Osakasayama Osaka, 589-8, Japan

Osakasayama Osaka, 589-8, Japan

Hidaka Saitama, 350-1, Japan

Kita-Adachigun Saitama, 362-0, Japan

Bunkyo-ku Tokyo, 113-8, Japan

Bunkyo-ku Tokyo, 113-8, Japan

Koto-ku Tokyo, 135-8, Japan

Chiba , 260-8, Japan

Chiba , 260-8, Japan

Fukuoka , 811-1, Japan

Fukuoka , 812-8, Japan

Kumamoto , 860-0, Japan

Miyazaki , 889-1, Japan

Osaka , 540-0, Japan

Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of

Seoul Seoul Teugbyeolsi, 06273, Korea, Republic of

Busan , 49241, Korea, Republic of

Daegu , 42601, Korea, Republic of

Incheon , , Korea, Republic of

Seoul , 03722, Korea, Republic of

Seoul , 05505, Korea, Republic of

Seoul , 137-7, Korea, Republic of

Bodø , 8092, Norway

Lørenskog , 1478, Norway

Oslo , 0424, Norway

Oslo , 0424, Norway

Bialystok , 15-02, Poland

Gdynia , 81-51, Poland

Gliwice , 44-10, Poland

Warszawa , 02-78, Poland

Moscow , 11547, Russian Federation

Obninsk , 24903, Russian Federation

Singapore , 11907, Singapore

Singapore , 16961, Singapore

Badalona (Barcelona) Barcelona, 08916, Spain

Palma de Mallorca Illes Baleares, 07120, Spain

A Coruña , 15009, Spain

Barcelona , 08035, Spain

Barcelona , 08036, Spain

Barcelona , 08041, Spain

Madrid , 28007, Spain

Madrid , 28033, Spain

Madrid , 28040, Spain

Madrid , 28041, Spain

Madrid , 28050, Spain

Málaga , 29010, Spain

Pamplona , 31008, Spain

Sevilla , 41013, Spain

Sevilla , 41071, Spain

Umeå , 901 8, Sweden

Kaohsiung , 81362, Taiwan

Taichung , 40705, Taiwan

Taipei , 11217, Taiwan

Taipei , , Taiwan

Taipei , , Taiwan

Taoyuan , 33305, Taiwan

Truro Cornwall, TR1 3, United Kingdom

Plymouth Devon, PL6 8, United Kingdom

Nottingham Nottinghamshire, NG5 1, United Kingdom

Taunton Somerset, TA1 5, United Kingdom

Sheffield South Yorkshire, S10 2, United Kingdom

Guildford Surrey, GU2 7, United Kingdom

Sutton Surrey, SM2 5, United Kingdom

Coventry Warwickshire, CV2 2, United Kingdom

Belfast , BT9 7, United Kingdom

Bristol , BS2 8, United Kingdom

Cottingham , HU16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 4

Estimated Enrollment:

800

Study ID:

NCT02312960

Recruitment Status:

Recruiting

Sponsor:


Bayer

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