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

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00836043
First received: February 2, 2009
Last updated: December 2, 2013
Last verified: December 2013

February 2, 2009
December 2, 2013
October 2008
April 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00836043 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Chronic Lymphocytic Leukemia
Drug: Alemtuzumab (MabCampath)
Intravenous therapy according to product information.
Other Name: BAY86-5045
Group 1
Intervention: Drug: Alemtuzumab (MabCampath)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2009
April 2009   (final data collection date for primary outcome measure)

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina,   Israel,   Macedonia, The Former Yugoslav Republic of
 
NCT00836043
13418, 13858, 14241, MC0701, STAR
No
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

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