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Autoimmune Hemolytic Anemia is a medical disorder in which autoantibodies produced by the immune system, specifically B-cells and plasma cells, attack the red blood cells and destroy them. Only 20% of patients treated with first line steroid therapy are cured, according to the authors, and only 20% of patients requiring long-term Prednisone doses above 15 mg/day are satisfied. Adding rituximab to steroids as the first line therapy improved outcomes compared to steroids alone, according to early studies. In one review, a similar number of patients responded to rituximab and steroid, relative to steroid alone, but the length of reaction was much longer for the rituximab arm. This report explores the use of daratumab therapy in this patient population due to the need for medical options for patients with refractory or relapsed AIHA who have already been treated with steroids and rituximab. Since they can live a long time and continue to produce the anti-red blood cell antibodies, they may be a significant source of resistance to rituximab. This trial seeks to investigate the safety of daratumumab in this new patient population, given the strong scientific evidence to support the use of daratumumab in treating patients with relapsed/refractory AIHA. The investigators intend to demonstrate the safety of daratumab treatment in AIHA patients and the clinical response, which will support future larger-scale clinical trials. In patients with relapsed/refractory AIHA, daratumumab's pharmacokinetics are uncertain, and may differ from other indications where daratumumab is used. Also, because the investigators anticipate that daratumab will kill the plasma cells responsible for producing the anti-RBC antibodies, the investigators will also monitor the anti-RBC antibody levels at baseline, and then at 3 months after the last dose; RBC antibody levels will be compared to clinical responses to determine potential correlation. The investigators do acknowledge that daratumab does bind to RBCs by poor expression of CD38 on RBCs. However, the Dartmouth-Hitchcock Medical Center Blood Bank director claims that by pretreating the test cells to remove CD38, the investigators can effectively remove the daratumumab from the specimen and, in turn, use dilutional techniques to determine the anti-RBC level.
Source link: https://clinicaltrials.gov/ct2/show/NCT05004259
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