Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

January 31, 2010

Study Completion Date

February 17, 2012

Conditions
Chronic Lymphocytic Leukemia
Interventions
BIOLOGICAL

Alemtuzumab i.v.

"Alemtuzumab will be administered once per week as a 2 h infusion~* Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration~* Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)~* Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"

BIOLOGICAL

Alemtuzumab s.c.

"Alemtuzumab will be administered once per week subcutaneously~* Dose level I: 10mg once weekly (start with dose escalation : 3 mg on day 1, 10mg on day 2) Duration~* Dose level II: 20mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 20mg on day 3)~* Dose level III: 30mg once weekly (start with dose escalation: 3mg on day 1, 10mg on day 2, 30mg on day 3)"

Trial Locations (6)

16225

Klinikum Barnim GmbH, Werner Forssmann Krankenhaus, Eberswalde

D-50924

Medizinische Universitaetsklinik I at the University of Cologne, Cologne

D-69115

Universitatsklinikum Heidelberg, Heidelberg

D-32657

Klinikum Lippe - Lemgo, Lemgo

D-68305

III Medizinische Klinik Mannheim, Mannheim

D-93049

Krankenhaus Barmherzige Brueder Regensburg, Regensburg

All Listed Sponsors
lead

German CLL Study Group

OTHER

NCT00634881 - Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter