Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is
high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will
recur after end of treatment or during the gradual reduction in dose of the drug. As a
result, many patients will finally be splenectomized or be treated with long-term
glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent
studies have shown however, that some patients will respond to treatment with the chimeric
anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the
studies, Rituximab has been used in refractory disease or at least as second line treatment.
In this study, patients with AIHA are randomized to receive either high-dose prednisolone
with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375
mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of
the patients in the two treatment arms. The primary treatment goal is a reduction in the
number of patients who obtain long-term complete or partial remission. The secondary
treatment goal is a reduction in patients who will be splenectomised or receive other
immunosuppressive drugs. Finally a comparison of side effects of the treatments will take
place.