Myelodysplastic Syndrome Clinical Trial

Clinical Trial Finder Myelodysplastic Syndrome Trials

Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

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Summary

The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

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Eligibility Criteria

Inclusion Criteria:

PNH > 6 months
Type III PNH red blood cell (RBC) clone by flow cytometry >10%
At least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic PNH
Lactate dehydrogenase (LDH) >1.5 x upper limit of normal
Must avoid conception
Willing and able to give written informed consent

Exclusion Criteria:

Platelet count of <30,000/mm3
Absolute neutrophil count <500/ul
Active bacterial infection
Hereditary complement deficiency
History of bone marrow transplantation
Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days
Pregnant, breast-feeding, or intending to conceive
History of meningococcal disease

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

85

Study ID:

NCT00122304

Recruitment Status:

Completed

Sponsor:

Alexion Pharmaceuticals

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There are 48 Locations for this study

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Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Stanford University Medical Center, Division of Hematology
Stanford California, 94305, United States
Hartford Hospital, Cancer Clinical Research Office
Hartford Connecticut, 06102, United States
Cleveland Clinic Florida, Dept. of Clinical Research
Weston Florida, 33331, United States
Indiana University Cancer Pavilion
Indianapolis Indiana, 46202, United States
Johns Hopkins University Medical Center
Baltimore Maryland, 21205, United States
National Heart, Lung, and Blood Institute, National Institutes of Health
Bethesda Maryland, 20892, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Mayo Clinic, Division of Hematology
Rochester Minnesota, 55905, United States
Washington University Medical Center, Department of Internal Medicine/Division of Hematology
St. Louis Missouri, 63110, United States
Cooper University Hospital, Cooper Cancer Institute
Voorhees New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Clinical Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10017, United States
Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program
Durham North Carolina, 27710, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
OHSU Center for Hematologic Malignancies
Portland Oregon, 97239, United States
Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program
Philadelphia Pennsylvania, 19104, United States
University of Utah, Hematology-BMT Department
Salt Lake City Utah, 84132, United States
Royal North Shore Hospital, Haematology Department
St. Leonard New South Wales, 2065, Australia
Princess Alexandra Hospital, Oncology Haematology Radiation Department
Woolloongabba Queensland, 4102, Australia
The Queen Elizabeth Hospital, Haematology/Oncology Department
Woodville South South Australia, 5011, Australia
The Royal Perth Hospital, Dept. of Haematology/Level 2
Perth Western Australia, 6000, Australia
Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology
Parkville , 3050, Australia
Ucl St. Luc, Hematology Department
Brussels , 1200, Belgium
University of Alberta, Cross Cancer Institute
Edmonton Alberta, T6G 2, Canada
London Regional Cancer Centre, Clinical Research Unit Room C3080
London Ontario, N6A 4, Canada
Hopital Saint-Louis, Centre d'investigation Clinique
Paris Cedex, 10 75, France
Universitatsklinikum Essen, Zentrum fur Innere Medizin
Essen , D-451, Germany
Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
Hannover , D-306, Germany
Universitatskliniken des Saarlandes, Innere Medizin 1
Homburg/Saar , D-664, Germany
Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionmedizin des Univer. Ulm
Ulm , D-890, Germany
St. James Hospital, Haematology Dept., Cancer Clinical Trial Office
Dublin , 8, Ireland
Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
Firenze , 50139, Italy
Ospedale San Martino, Dept. of Hematology
Genova , I-161, Italy
Ospedale Maggiore di Milano, Divisione di Ematologia
Milano , 35-20, Italy
Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
Napoli , 5-801, Italy
Ospedale San Bortolo, Divisione di Ematologia
Vicenza , 37-36, Italy
UMC St. Radboud, Department of Hematology
Nijmegen , 6525 , Netherlands
Hospital Clinic i Provincial, Servicio de Hematologia
Barcelona , 08036, Spain
Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia
Barcelona , 08916, Spain
Hospital De La Paz, Servicio de Hematologia
Madrid , 28046, Spain
Stockholm South Hospital, Division of Hematology
Stockholm , 118-8, Sweden
University Hospital, Dept. of Haematology
Uppsala , SE-75, Sweden
Kantonsspital Basel, Abteilung fuer Haematologie
Basel , CH-40, Switzerland
Royal Cornwall Hospital
Truro Cornwall, TR1 3, United Kingdom
Leeds General Infirmary, D Floor Brotherton Wing
Leeds , LS1 3, United Kingdom
St. Georges Hospital, Department of Haematology
London , 17 OQ, United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

85

Study ID:

NCT00122304

Recruitment Status:

Completed

Sponsor:


Alexion Pharmaceuticals

How clear is this clinincal trial information?

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