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

Phase 4

Completed

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
• Interventions: Drug: Fludarabine Phosphate (Fludara)

• Registration Number: NCT00220311
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-22
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Fludarabine Phosphate (Fludara)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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