Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions
Anemia, Sickle Cell
About this trial
This is an interventional treatment trial for Anemia, Sickle Cell focused on measuring Sickle cell disease, iron overload, deferoxamine, hemosiderosis
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 2 years Sickle cell disease patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day Serum ferritin greater than 1000 mg/ml Liver iron content greater than 2 mg iron/g dw assessed by means of superconducting quantum interference device (SQUID) for patients who receive simple transfusions and greater than 5 mg iron/ g dw for patients who receive exchange transfusions or who have a history of intermittent blood transfusion. Regular transfusion aimed at maintaining % Hb A above 50% or a previous history of simple transfusion being the recipient of at least 20 units of packed red blood cells. Exclusion Criteria: Chronic anemias other than sickle cell disease Documented toxicity to deferoxamine Elevated liver enzymes in the year preceeding enrollment Active hepatitis B or hepatitis C HIV seropositivity Elevated serum creatinine or significant proteinuria History of nephrotic syndrome Uncontrolled systemic hypertension Fever and other signs/symptoms of infection within 10 days prior to the start of the study Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval (other than beta-adrenergic receptor blocking agents). Diseases (cardiovascular, renal, hepatic, etc.) that would prevent the patient from undergoing any of the treatment options Psychiatric or addictive disorders that would prevent the patient from giving informed consent History of drug or alcohol abuse within the 12 months prior to the study Pregnant or breast feeding patients Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of the study Patients who require concomitant therapy with hydroxyurea Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function Non-compliant or unreliable patients Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography Patients unable to undergo SQUID examination
Sites / Locations
- U. of S. Alabama Medical Center
- Loma Linda University Medical Center
- Children's Hospital Los Angeles
- Children's Hospital & Research Center
- Colorado Sickle Cell Treatment and Research Center
- Howard University Hospital
- Tampa Children's Hospital at St Joseph's
- Georgia Comprehensive Sickle cell Center, Grady Hospital
- Adult Sickle Cell Clinic, Medical College of Georgia
- University of Illinois at Chicago
- Children's Memorial Hospital
- Tulane University Sickle Cell Center
- Children's Hospital, Department of Hematology/Oncology
- Children's Hospital Boston, Division of Hematology/Oncology
- Boston Medical Center
- Karmanos Cancer Institute
- NY Methodist Hospital
- Weill Medical College of Cornell University
- U. Of Rochester Medical Center
- Sickle Cell Center, Montefiore Hospital
- Wake Forest University School of Medicine
- Barrett Center, University of Cincinnati
- Children's Hospital Medical Center
- James Cancer Hospital
- Penn State Milton S Hershey Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Liberty Hematology Oncology Center
- Palmetto Health Clinical Trials
- Santee Hematology/Oncology
- Baylor College of Medicine
- Texas Children's Hospital/Baylor College of Medicine
- Scott and White Memorial Hospital & Clinics
- Children's Hospital of the King's Daughter
Arms of the Study
Arm 1
Experimental
ICL670 + deferoxamine