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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 21, 2005

Last Updated Date

January 22, 2009

Start Date ^†

November 2000

Current Primary Outcome Measures ^†

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) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00220311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings [ Time Frame: Up to 6 treatment cycles (at about 6 months) ] [ Designated as safety issue: No ]
Duration of response and change of peripheral blood findings [ Time Frame: End of study ] [ Designated as safety issue: No ]

Original 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

Descriptive Information

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 Fludarabine Phosphate Administered in 6 Treatment Cycles (1 Cycle: 5 Treatment Days Every 28 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

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

This study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Chronic Lymphocytic Leukemia

Intervention ^†

Drug: Fludarabine Phosphate (Fludara, BAY86-4864)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2005

Primary Completion Date

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

Gender

Both

Ages

15 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00220311

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer Yakuhin Ltd.

Secondary IDs ^††

303530

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.