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

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

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

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

Study Overview

Status

Terminated

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

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)

Description

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).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Alemtuzumab (MabCampath)
Intravenous therapy according to product information.
Other Names:
  • BAY86-5045

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
Time Frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months
After first cycle of treatment, e.g. 12 weeks, then after 9 months

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

October 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13418
  • STAR
  • 14241
  • 13858
  • MC0701

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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