A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

June 30, 2015

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Bendamustine, Rituximab, Lenalidomide

"Bendamustine: 50 mg/m2, i.v., day 1+2~Rituximab: Cycle 1: 375 mg/m2, i.v. day 0; Cycle 2-6: 500mg/m2, i.v., day 1~Lenalidomide:~* Dose level 1: Cycle 1-6: 2,5mg p.o., d1-28~* Dose level 2: Cycle 1: 2,5mg p.o., d1-28; Cycle 2-6: 5mg p.o., d1-28~* Dose level 3: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3-6: 10 mg p.o., d1-28~* Dose level 4: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3: 10 mg p.o.,d1-28, Cycle 4-6: 15 mg p.o.,d1-28~* Dose level 5: maximal tolerated dose"

Trial Locations (1)

50924

University Hospital of Cologne, Cologne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mundipharma Research GmbH & Co KG

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

collaborator

Celgene

INDUSTRY

lead

German CLL Study Group

OTHER