A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma

Exclusion Criteria

• •1. Diagnosis of grade 3b follicular lymphoma or transformed lymphoma of any grade
• •2. Previously received TRU-016
• •3. Prior treatment with rituximab if subject discontinued rituximab due to unresolved toxicity
• •4. Refractory to bendamustine, defined as follows:
• •* progression within 6 months of last dose of bendamustine
• •* failed to achieve at least a PR while receiving bendamustine
• •* discontinued bendamustine due to toxicity
• •* received bendamustine within 6 months prior to first dose of study drug
• •5. Received chemotherapy, radiotherapy, or immunotherapy including investigational agents within 28 days prior to the first dose of study drug
• •6. Received therapeutic corticosteroids at doses equivalent to \>10 mg prednisone per day for longer than 5 days within 14 days prior to the first dose of study drug, except if needed as a pre-medication
• •7. Received filgrastim or equivalent within 14 days prior to screening (ie, collection of samples for laboratory tests) or pegfilgrastim within 28 days prior to screening (ie, collection of samples for laboratory tests)
• •8. Prior allogeneic bone marrow transplant
• •9. Prior autologous bone marrow transplant within 12 months prior to the first dose of study drug
• •10. Received blood or platelet infusion within 7 days prior to screening (ie, collection of samples for laboratory tests)
• •11. Previous or concurrent additional malignancy except non-invasive, non-melanomatous skin cancer or in situ carcinoma of the cervix, or other solid tumors if the subject has been disease-free for a minimum of 2 years prior to the first dose of study drug
• •12. Known central nervous system or leptomeningeal lymphoma
• •13. Any significant concurrent medical diseases or conditions, including but not limited to the following:
• •* Clinically significant pulmonary dysfunction requiring oxygen therapy
• •* An active infection (viral, bacterial, or fungal) requiring systemic therapy; subjects receiving prophylactic therapy are eligible
• •14. Known allergy to mannitol
• •15. History of positive serology for human immunodeficiency virus (HIV)
• •16. Positive serology for hepatitis B (surface antigen or core antibody) Note: If a positive test result for hepatitis B core antibody is due to immunoglobulin treatment, the subject may be enrolled if the hepatitis B viral deoxyribonucleic acid (DNA) is negative.
• •17. Positive serology for hepatitis C
• •18. Pregnant or breastfeeding
• •19. Other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with safety
• •20. Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation