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

Genzyme

Status: Terminated

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Alemtuzumab (MabCampath)

Study type: Observational

Funder types: Industry

Identifiers

NCT00836043

14241

MC0701

13858

STAR

13418

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

6 participants in 1 patient group

Group 1

Treatment:

Drug: Alemtuzumab (MabCampath)