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


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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.


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

After first cycle of treatment, e.g. 12 weeks, then after 9 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

Bosnia: Federal Ministry of Health

Study ID:

13418

NCT ID:

NCT00836043

Start Date:

October 2008

Completion Date:

April 2009

Related Keywords:

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

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