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

NCT ID: NCT00220311

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Leukemia, Lymphocytic, Chronic, B-Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Fludarabine Phosphate (Fludara)

Intervention Type DRUG

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

Interventions

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Fludarabine Phosphate (Fludara)

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

Intervention Type DRUG

Other Intervention Names

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BAY86-4864

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Countries

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Japan

Other Identifiers

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90699

Identifier Type: -

Identifier Source: secondary_id

303530

Identifier Type: -

Identifier Source: org_study_id