Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Fludarabine

25 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

DRUG

Cyclophosphamide

250 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.

DRUG

Alemtuzumab

30 mg IV on Days 1, 3 and 5 over 2-4 hours; repeated every four weeks for a total of 6 planned cycles.

DRUG

Rituximab

"Cycle 1 (Week 1): 375 mg/m\^2/day IV on Day 2 over 4- 6 hours~Cycle 2 - 6 (Week 1): 500 mg/m\^2/day IV on Day 2 over 4- 6 hours"

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER