Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

July 31, 2006

Study Completion Date

September 30, 2006

Conditions
B-Chronic Lymphocytic Leukemia
Interventions
DRUG

Pentostatin

2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.

DRUG

Rituximab

For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.

DRUG

Cyclophosphamide

600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

Trial Locations (1)

43210

Ohio State University, Columbus

Sponsors
All Listed Sponsors
collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

lead

Ohio State University Comprehensive Cancer Center

OTHER