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

Launched by CTI BIOPHARMA · Dec 17, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)
• • 2. Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms
• • 3. CD 20+ lymphoma (confirmed by immunochemistry)
• • 4. Measurable disease.
• • 5. Atleast 1 prior therapy.
• • 6. Age ≥ 18 years
• • 7. Life expectancy of at least 3 months
• • 8. ECOG performance status (PS) of 0 or 1
• • 9. Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan
• • 10. Adequate renal function
• • 11. Adequate hepatic function
• • 12. Adequate bone marrow function
• • 13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).
• • 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