A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate
 administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in
 untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.
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 CLL

 -  Patients with hemoglobin concentration and/or platelet count below the institution's
 lower limit of normal

 -  Patients who have not received cancer chemotherapy or radiotherapy

 Exclusion Criteria:

 -  Patients with apparent infections (including viral infections)

 -  Patients with serious complications (heart, liver, or kidney disease, etc.)

 -  Patients with a serious bleeding tendency (e.g., DIC)

 -  Patients with serious CNS symptoms

 -  Patients with fever >= 38°C (excluding tumor fever)

 -  Patients with interstitial pneumonia or pulmonary fibrosis

 -  Patients with active multiple cancers

 -  Patients receiving other investigational products within 6 months before registration
 in this study

 -  Patients with prior allergies to medications that are similar to the investigational
 product (purine nucleoside derivatives)

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