Combination Study Halted
The National Heart, Lung and Blood Institute has halted its Cardiac Deferoxamine/L1 Study due to an inability to enroll a sufficient number of patients to provide statistically relevant results.
The purpose of the study was to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims included evaluating changes in myocardial iron burden using T2* and estimating the relative incidence and severity of chelator-induced toxicity.
Participants in the trial have been contacted by their physicians about the cessation of the trial and have been advised of treatment options to consider moving forward. Patients and physicians who agree that continuing a treatment course involving deferiprone have the option of obtaining the drug through a treatment IND (e.g., “Compassionate Use”) program.
If you have any questions concerning this issue, please contact CAF at (800) 522-7222 (212) 279-8090 or eva.chin@cooleysanemia.org info@thalassemia.org.