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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Genzyme

ClinicalTrials.gov Identifier:

NCT00220311

First received: September 21, 2005

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2005

Last Updated Date

March 4, 2013

Start Date ^ICMJE

November 2000

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)

Change History

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

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

-Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
Duration of response and change of peripheral blood findings

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Leukemia, Lymphocytic, Chronic, B-Cell

Intervention ^ICMJE

Drug: Fludarabine Phosphate (Fludara)

6 cycles (1 cycle: 5 treatment days every 28 days)

Other Name: BAY86-4864

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Fludarabine Phosphate (Fludara)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00220311

Other Study ID Numbers ^ICMJE

303530, 90699

Has Data Monitoring Committee

Responsible Party

Genzyme

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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