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

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ClinicalTrials.gov Identifier: NCT00836043
Recruitment Status : Terminated (Study terminated due to low enrollment.)
First Posted : February 4, 2009
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: Alemtuzumab (MabCampath)

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
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)
Study Start Date : October 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009


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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836043


Locations
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Israel
Many Locations, Israel
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company

Additional Information:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00836043     History of Changes
Other Study ID Numbers: 13418
13858
14241
MC0701
STAR
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
CLL
alemtuzumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents