Protocol Number: 05-H-0244
Patients 2 years of age or older with pure red cell aplasia or Diamond Blackfan anemia and patients 18 years of age or older with moderate aplastic anemia who did not respond to previous immunosuppressive therapy or relapsed after treatment may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, electrocardiogram, and bone marrow biopsy (withdrawal of a mall sample of bone marrow through a needle). Participants receive four doses of rituximab, once a week for 4 weeks through a needle in an arm vein. The infusion rate depends on how well the patient tolerates the drug. The first infusion usually takes 4 to 6 hours and the rest take 3 to 4 hours. The first and fourth infusions are given at NIH; the second and third may be given at NIH or by a patient's referring doctor. Patients who respond to rituximab but then relapse may receive one additional course of four doses. Patients may continue with transfusions and their current medications, including growth factors (e.g., Epogen and Neupogen) while on study, but may have to stop taking immunosuppressive drugs, such as prednisone or cyclosporine. Patients who must start another immunosuppressive medication are taken off rituximab and followed for safety with clinic visits one week and then once a month for 6 months after the first dose of rituximab. Patients have a blood test once a week while receiving rituximab to evaluate blood counts. After treatment is completed, patients are evaluated once a month until 6 months, then once a year until 3 years to monitor the response to treatment and any drug side effects. Patients are evaluated at NIH for the 3- and 6-month visits and the annual visits. They may be seen at NIH or by their referring doctors for the 1-, 2-, 4- and 5-month visits. A blood test is done at every visit, and a bone marrow aspiration and biopsy are done at the 3-month visit (and when clinically needed to evaluate the effect of rituximab on bone marrow cells).
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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