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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Fludarabine Phosphate (Fludara)
6 cycles (1 cycle: 5 treatment days every 28 days)
Other Names:
  • BAY86-4864

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Up to 6 treatment cycles (at about 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
Time Frame: Up to 6 treatment cycles (at about 6 months)
Up to 6 treatment cycles (at about 6 months)
Duration of response and change of peripheral blood findings
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303530
  • 90699

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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