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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220311
• Other study ID #: 303530
• Secondary ID: 90699
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: December 2, 2013
• Start date: November 2000
• Est. completion date: September 2005

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)		Up to 6 treatment cycles (at about 6 months)	No
Secondary	Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings		Up to 6 treatment cycles (at about 6 months)	No
Secondary	Duration of response and change of peripheral blood findings		End of study	No

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