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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Leukemia, Lymphocytic, Chronic, B-Cell

Intervention / Treatment
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* Drug: Fludarabine Phosphate (Fludara)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Fludarabine Phosphate (Fludara)<br>* 6 cycles (1 cycle: 5 treatment days every 28 days)<br>* Other names: BAY86-4864;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months) |  | Up to 6 treatment cycles (at about 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings |  | Up to 6 treatment cycles (at about 6 months) | 
| Duration of response and change of peripheral blood findings |  | End of study |