Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
Hemoglobinuria, Paroxysmal
About this trial
This is an interventional educational/counseling/training trial for Hemoglobinuria, Paroxysmal
Eligibility Criteria
Inclusion Criteria: Must have required at least 4 transfusions in the past 12 months PNH type III red blood cell (RBC) clone by flow cytometry of >10% Lactate dehydrogenase (LDH) level > 1.5 x upper limit of normal Platelet count > 100,000/mm3 Patient taking erythropoietin must be on a stable dose for at least 26 weeks Patient taking immunosuppressants must be on a stable dose for at least 26 weeks Patient taking corticosteroids must be on a stable dose for at least 4 weeks Patient taking coumadin must be at a stable INR for at least 4 weeks Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks Willing and able to give written informed consent Must avoid conception Exclusion Criteria: Mean hemoglobin level prior to transfusion over the previous 12 months is >10.5 gm/dl Absolute neutrophil count <500/ul Active bacterial infection Hereditary complement deficiency Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days Pregnant, breast-feeding, or intending to conceive History of meningococcal disease History of bone marrow transplantation
Sites / Locations
- City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant
- University of California at Los Angeles
- Scripps Cancer Center
- Stanford University Medical Center, Division of Hematology
- Hartford Hospital, Cancer Clinical Research Office
- Cleveland Clinic, Dept. of Clinical Research
- Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology
- Johns Hopkins University Medical Center
- National Heart, Blood, and Lung Institute, National Institutes of Health
- Massachusetts General Hospital
- Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology
- NYU Clinical Cancer Center
- Memorial Sloan Kettering Cancer Center
- Duke University Health System, Division of Cell Therapy, Heme Malignancies Program
- Cleveland Clinic Foundation
- Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program
- Princess Alexandra Hospital, Oncology Haematology Radiation Department
- Queen Elizabeth Hospital, Dept. of Haematology
- Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology
- The Royal Perth Hosptial, Department of Haematology/Level 2
- Ucl St. Luc, Hematology Department
- University of Alberta, Cross Cancer Institute
- Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale
- Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle
- Universitatsklinikum Essen, Zentrum fur Innere Medizin
- Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie
- Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin
- Saarland University Medical School, Internal Medicine 1
- Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm
- St. James Hospital, Haematology Department
- Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica
- Ospedale San Martino, Dept. of Hematology
- Ospedale Maggiore di Milano, Divisione di Ematologia
- Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico
- Ospedale San Bortolo, Divisione di Ematologia
- UMC St. Radboud, Dept. of Hematology
- Lund University Hospital, Department of Internal Medicine, Section of Hematology
- Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology
- Universitatsklinik Basel, Division of Hematology
- Royal Cornwall Hospital, Haematology Dept.
- Belfast City Hospital, Dept. of Haematology C Floor
- Leeds General Infirmary, D Floor Brotherton Wing
- St. George's Hospital, Department of Haematology