Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2010

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Oblimersen-rituximab-fludarabine

28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab

Trial Locations (3)

11040

Long Island Jewish Medical Center, New Hyde Park

14263

Roswell Park Cancer Institute, Buffalo

20007

Georgetown University Medical Center/Lombardi Cancer Center, Washington D.C.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY