Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
DRUG

Lenalidomide

"Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity.~During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage."

DRUG

Fludarabine

25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.

BIOLOGICAL

Rituximab

"Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6.~Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage."

Trial Locations (7)

A-6020

Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie, Innsbruck

A-6806

Landeskrankenhaus Feldkirch, Feldkirch

A-4010

Krankenhaus d. Barmherzigen Schwestern Linz, Linz

Krankenhaus der Elisabethinen Linz GmbH, Linz

A-4020

Krankenhaus der Stadt Linz, Linz

A-5020

Universitaetsklinik f. Innere Medizin III, Salzburg

A-4600

Klinikum Wels-Grieskirchen GmbH, Wels

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER