Back to resultsA Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Primary Purpose
Leukemia, Lymphocytic, Chronic, B-Cell
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fludarabine Phosphate (Fludara)
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
Secondary Outcome Measures
Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
Duration of response and change of peripheral blood findings
Full Information
NCT ID
NCT00220311
First Posted
September 21, 2005
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00220311
Brief Title
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.
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, Germany.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic, B-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate (Fludara)
Other Intervention Name(s)
BAY86-4864
Intervention Description
6 cycles (1 cycle: 5 treatment days every 28 days)
Primary Outcome Measure Information:
Title
Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
Time Frame
Up to 6 treatment cycles (at about 6 months)
Secondary Outcome Measure Information:
Title
Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
Time Frame
Up to 6 treatment cycles (at about 6 months)
Title
Duration of response and change of peripheral blood findings
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
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