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

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: Fludarabine Phosphate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Berlex, medical affairs, Region Japan, Study Director, Affiliation: Tel. 1-800-BERLEX4

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.

Official title: A Multicenter Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in 6 Treatment Cycles (1 Cycle: 5 Treatment Days Every 28 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)

Secondary outcome:

-Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings

Duration of response and change of peripheral blood findings

Detailed description: This study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Minimum age: 15 Years. Maximum age: 80 Years. Gender(s): Both.

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

Starting date: November 2000
Last updated: April 30, 2007