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Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia

NCT ID: NCT00836043

Last Updated: 2013-12-03

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

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-04-30

Brief Summary

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This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.

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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Chronic Lymphocytic Leukemia

Keywords

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CLL alemtuzumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Alemtuzumab (MabCampath)

Intervention Type DRUG

Intravenous therapy according to product information.

Interventions

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Alemtuzumab (MabCampath)

Intravenous therapy according to product information.

Intervention Type DRUG

Other Intervention Names

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BAY86-5045

Eligibility Criteria

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Inclusion Criteria

In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

Exclusion Criteria

In accordance with Summaries of Product Characteristics (SPC).
Minimum Eligible Age

18 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

Locations

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Many Locations, , Bosnia and Herzegovina

Site Status

Many Locations, , Israel

Site Status

Many Locations, , North Macedonia

Site Status

Countries

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Croatia Jordan Morocco Romania Serbia Turkey (Türkiye) Ukraine Bosnia and Herzegovina Israel North Macedonia

Other Identifiers

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13858

Identifier Type: -

Identifier Source: secondary_id

14241

Identifier Type: -

Identifier Source: secondary_id

MC0701

Identifier Type: -

Identifier Source: secondary_id

STAR

Identifier Type: -

Identifier Source: secondary_id

13418

Identifier Type: -

Identifier Source: org_study_id