A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Information source: Bayer
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia
Intervention: Fludarabine Phosphate (Drug)
Phase: Phase 4
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)
-Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
Duration of response and change of peripheral blood findings
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.
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
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
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
Locations and Contacts
Starting date: November 2000
Last updated: April 30, 2007