Immune Thrombocytopenia Clinical Trial
Official title:
A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia
Some patients with antibody-mediated autoimmune hematological diseases (warm autoimmune
hemolytic anemia (wAIHA), cold agglutinin disease (cAIHA) and immune thrombocytopenia (ITP))
shows no or only minor and transient response to therapy despite several treatment-lines.
Such patients are more likely to have a severe disease, with a higher morbidity and
mortality.
Hypothesis Effective depletion of autoreactive plasma cells might be the key for a curative
approach of these diseases. Therefore, there is a rationale for using proteasome inhibitors
(PIs) in these refractory patients.
The rationale is that non-tumoral autoreactive plasma cells are rapidly targeted by
proteasome inhibitors. It led us to propose a short course of dexamethasone and ixazomib (5
cycles), to evaluate the safety/efficacy of this innovative strategy of treatment.
Method Prospective interventional uncontrolled single arm open study evaluating the rate of
patients achieving 5 cycles of ixazomib and dexamethasone without severe toxicity and
response on therapy.
n/a
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