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:

255

Study ID:

NCT02312960

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 115 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

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

Fitzroy Victoria, 3065, Australia

Heidelberg Victoria, 3084, Australia

Kortrijk , 8500, Belgium

Leuven , 3000, Belgium

Porto Alegre Rio Grande Do Sul, 90020, Brazil

Barretos/SP Sao Paulo, 14784, Brazil

São Paulo Sao Paulo, 01246, Brazil

Toronto Ontario, M4N 3, Canada

Montreal Quebec, H2X 0, Canada

Praha 2 , 128 0, Czechia

Helsinki , 00290, Finland

Tampere , FIN-3, Finland

Bordeaux Cedex , 33076, France

Nantes , 44805, France

Nîmes , 30029, France

Saint-Cloud , 92210, France

Tours , 37044, France

Villejuif , 94805, France

Ulm Baden-Württemberg, 89091, Germany

Erlangen Bayern, 91054, Germany

München Bayern, 81377, Germany

Rostock Mecklenburg-Vorpommern, 18107, Germany

Aachen Nordrhein-Westfalen, 52074, Germany

Mainz Rheinland-Pfalz, 55131, Germany

Magdeburg Sachsen-Anhalt, 39120, Germany

Dresden Sachsen, 01307, Germany

Jena Thüringen, 07747, Germany

Berlin , 10719, Germany

Berlin , 12203, Germany

Bremen , 28277, Germany

Chai Wan , 0, Hong Kong

Afula , 18341, Israel

Haifa , 31096, Israel

Jerusalem , 91120, Israel

Petach Tikva , 49414, Israel

Ramat Gan , 52620, Israel

Tel Aviv , 64239, Israel

Zrifin , 70300, Israel

Forlì Cesena Emilia-Romagna, 47014, Italy

Modena Emilia-Romagna, 41124, Italy

Roma Lazio, 00161, Italy

Roma Lazio, 00189, Italy

Milano Lombardia, 20133, 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

Kurashiki Okayama, 701-0, Japan

Osakasayama Osaka, 589-8, Japan

Hidaka Saitama, 350-1, Japan

Kita-Adachigun Saitama, 362-0, Japan

Koto-ku Tokyo, 135-8, Japan

Fukuoka , 811-1, Japan

Kumamoto , 860-0, Japan

Miyazaki , 889-1, Japan

Osaka , 540-0, Japan

Seoul Seoul Teugbyeolsi, 3080, Korea, Republic of

Seoul Seoul Teugbyeolsi, 6273, Korea, Republic of

Daegu , 42601, Korea, Republic of

Incheon , , Korea, Republic of

Seoul , 138-7, Korea, Republic of

Seoul , 3722, Korea, Republic of

Bodø , 8092, Norway

Oslo , 0424, Norway

Bialystok , 15-02, Poland

Gliwice , 44-10, Poland

Warszawa , 02-78, Poland

Obninsk , 24903, Russian Federation

Singapore , 11907, Singapore

Singapore , 16858, Singapore

Badalona (Barcelona) Barcelona, 08916, Spain

Palma De Mallorca Illes Baleares, 7120, Spain

A Coruña , 15009, Spain

Barcelona , 08035, Spain

Barcelona , 08036, Spain

Barcelona , 08041, Spain

Madrid , 28007, Spain

Madrid , 28040, Spain

Madrid , 28050, Spain

Málaga , 29010, Spain

Pamplona , 31008, Spain

Sevilla , 41013, Spain

Sevilla , 41071, Spain

Umea , 901 8, Sweden

Kaohsiung , 81362, Taiwan

Taichung , 40705, Taiwan

Taipei , 11217, Taiwan

Taipei , , Taiwan

Taoyuan , 33305, Taiwan

Truro Cornwall, TR1 3, United Kingdom

Plymouth Devon, PL6 8, 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

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:

255

Study ID:

NCT02312960

Recruitment Status:

Completed

Sponsor:


Bayer

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