Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated CLL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

October 31, 2015

Conditions
CLLChronic Lymphocytic Leukemia
Interventions
DRUG

Lenalidomide

"Lenalidomide: day 8-21 of cycle 1 and day 1-21 of cycles 2-6; Starting Dose: 5 mg (first 5 patients) and 10 mg (further 5 patients) increase Lenalidomide dose via dose levels (10)/15/20/25 mg/d every 28 days if no limiting toxicity occurs~Fludarabine: 25 mg/m2 iv d1-3 or 40 mg/m2 po d1-3; repeat every 28 days~Rituximab: 375 mg/m2 iv day 4 on cycle 1 and 500 mg/m2 iv day 1 on cycles 2-6; repeat every 28 days"

Trial Locations (2)

5020

Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin III, Salzburg

6020

Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie, Innsbruck

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

NCT01703364 - Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated CLL | Biotech Hunter | Biotech Hunter