Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL

Exclusion Criteria

• •1. Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2
• •2. Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start
• •3. Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.
• •4. Radioimmunotherapy (RIT) within 3 months of treatment start
• •5. Known hypersensitivity to the excipients or the study drugs that the patient will receive
• •6. Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab
• •7. Major thoracic and/or abdominal surgery in the preceding 4 weeks, from which the patient has not fully recovered (patients who have had minor surgery and one week's recovery period may be enrolled)
• •8. HIV-related lymphoma
• •9. Active CNS involvement
• •10. Clinically significant cardiovascular abnormalities
• •11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.
• •12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
• •13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .
• •14. History of another malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years
• •15. Pregnant or lactating women
• •16. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration