Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Inclusion 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