Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
The purpose of this study is to assess the antitumor effect and safety of fludarabine
 phosphate tablet in combination with rituximab in patient with indolent lymphoma.
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was
 originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer
 Schering Pharma AG, Germany.
Inclusion Criteria:

 -  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
 allowed.)

 -  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.

 Exclusion Criteria:

 -  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
 rituximab.

 -  Women who are pregnant, of childbearing potential, or lactating.

 -  Patients who do not agree to practice contraception.