NOX-A12 in Combination With Bendamustine and Rituximab in Relapsed Chronic Lymphocytic Leukemia (CLL)

Exclusion Criteria

• •1. Relapse of B-cell CLL within 12 months after last chemotherapy.
• •2. Subjects who have progressed to more aggressive B-cell cancers such as Richter's syndrome.
• •3. CLL with documented loss of the short arm of chromosome 17 (17p-) associated with the loss of p53.
• •4. The subject has a history of or is clinically suspicious for cancer-related Central Nervous System disease.
• •5. Patients at risk of hemostasis or spleen rupture.
• •6. Autoimmune hemolytic anemia.
• •7. Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for allo SCT as assessed by their treating physician
• •8. Patient has a history of other active malignancies within three years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
• •9. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
• •10. Female subject is pregnant or breast-feeding.
• •11. Known infection with HIV, active Hepatitis B or Hepatitis C.
• •12. The patient has a history of prior toxicity from bendamustine or rituximab that resulted in permanent discontinuation of treatments.
• •13. Treatment with other investigational drugs, or participation in another clinical trial within 30 days prior to study drug administration.
• •14. Uncontrolled hypertension (defined as systolic blood pressure (BP) \> 160 mm Hg or diastolic BP \> 100 mm Hg).
• •15. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration.
• •16. Systemic illnesses or other severe concurrent disease including alcoholism which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
• •17. Known or suspected of not being able to comply with the trial protocol.
• •18. Having been previously enrolled in this clinical trial.
• •19. Known hypersensitivity to rituximab or to any of the excipients or to murine proteins
• •20. History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infection.
• •21. Known hypersensitivity to bendamustine or to mannitol.
• •22. Invasive surgery within 30 days prior to study drug administration.