A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

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