A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
15 Years
80 Years
Both
Leukemia, Lymphocytic, Chronic, B-Cell
Trial Information
A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
Outcome Time Frame:
Up to 6 treatment cycles (at about 6 months)
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Genzyme
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
303530
NCT ID:
NCT00220311
Start Date:
November 2000
Completion Date:
September 2005
Related Keywords:
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Thrombocytopenia
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