A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
- Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of
prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are
- Patients with measurable lesions (> 1.5 cm).
- Patients who have not received any treatment for more than 4 weeks after completing
previous therapies (6 months in the case of antibody therapies).
- ECOG performance status: 0 - 1
- Patients with adequately maintained organ functions.
- Patients with infectious disease, serious complications, serious gastrointestinal
symptoms, serious bleeding tendency, serious CNS symptoms, fever =38 °C,
interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune
hemolytic anemia or the history of the disease, or glaucoma.
- Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
- Patients who received G-CSF or transfusion within 1 week before the registration.
- Patients with the history of allergies to purine nucleoside analogue.
- Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or
mouse protein-derived products.
- Patients who had ever received prior therapy with fludarabine phosphate injection,
pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody
therapy other than rituximab to NHL (including radioimmunotherapy).
- Patients who had progressive disease within 6 months of receiving therapy including
- Women who are pregnant, of childbearing potential, or lactating.
- Patients who do not agree to practice contraception.