The PROLONG Trial - Rituximab Maintenance Therapy in ITP

Exclusion Criteria

• •1. Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, aziothioprin, cyclosporine), chemotherapy or splenectomy.
• •2. Pregnancy or lactation.
• •3. Known active gastro-duodenal ulcer.
• •4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, autoimmune disorders such as, common variable immune deficiency, human immunodeficiency virus, or hepatitis C or thrombocytopenia associated with myeloid dysplasia.
• •5. Concomitant autoimmune hemolytic anemia.
• •6. History of any major cardiovascular event within the 6 months prior to randomization, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, or New York Heart Association Class III or IV heart failure.
• •7. Active hepatitis B virus or patients with positive HBsAG or HBcAB.
• •8. Patients with active severe infection, including systemic mycotic infections or a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection.
• •9. Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or any of the ingredients.
• •10. Patients in a severely immune compromised state.
• •11. Known contraindication to a treatment with any proton-pump inhibitor.
• •12. Active malignancy or history of malignant disease during the last 2 years except cured skin cancer.
• •13. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
• •15\. Pregnancy. 16. Treatment with rescue medication after week 18. 17. Patients refusing to continue in the study (withdrawal of consent). 18. Splenectomy performed for any cause.
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