A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

February 13, 2008

Study Completion Date

February 13, 2008

Conditions
B-cell Chronic Lymphocytic Leukemia
Interventions
DRUG

Fludarabine phosphate

orally, 40 mg/m2 d1-3 q4w, x4 cycles

DRUG

Alemtuzumab

subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose

Trial Locations (8)

A-6806

Landeskrankenhaus Feldkirch, Feldkirch

A-8280

A.ö. Landeskrankenhaus Fürstenfeld, Fürstenfeld

A-6020

Universitätsklinik Innsbruck/ Klinik für Innere Medizin, Innsbruck

A-8700

A.ö. Landeskrankenhaus Leoben, Leoben

A-4020

Krankenhaus der Stadt Linz, Linz

A-5020

St. Johanns LK, Salzburg

A-3100

A.ö. Krankenhaus der Landeshauptstadt St. Pölten, Sankt Pölten

A-4600

Klinikum Kreuzschwestern Wels GmbH, Wels

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER