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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00836043
• Other study ID #: 13418
• Secondary ID: 1385814241MC0701
• Status: Terminated
• Phase: N/A
• First received: February 2, 2009
• Last updated: December 2, 2013
• Start date: October 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia: Federal Ministry of HealthJordan: Ethical CommitteeRomania: State Institute for Drug ControlSerbia: Ethics CommitteeCroatia: Agency for Medicinal Product and Medical DevicesCroatia: Ethics CommitteeCroatia: Ministry of Health and Social CareCroatia: Ministry of Science, Education and SportsUkraine: Ministry of HealthMacedonia: Ministry of HealthMorocco: Ministry of Public HealthTurkey: Ethics CommitteeTurkey: Ministry of HealthIsrael: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Alemtuzumab (MabCampath)
Intravenous therapy according to product information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Israel,  Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		After first cycle of treatment, e.g. 12 weeks, then after 9 months	Yes

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