Status:
COMPLETED
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
15-80 years
Phase:
PHASE4
Brief 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 ly...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00220311
Start Date
November 1 2000
End Date
September 1 2005
Last Update
December 4 2013
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