Fludara (Oral) Phase II Study for Indolent Lymphoma

A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma

To assess the antitumor effect and safety of Fludara in patients 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 histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
• Patients with measurable lesions (major axis > 1.5 cm by CT)
• Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
• Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
• Patients who have PS Grade 0 to 2 in the criteria of ECOG
• Patients with adequately maintained organ functions

Exclusion Criteria:

• Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
• Patients who are positive for HBs antigen, HCV antibody or HIV antibody
• Patients who received G-CSF or blood transfusion within 1 week before the screening test
• Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
• Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception