A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
This single arm, open-label study will assess the safety and efficacy of low dose fludarabine
 and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as
 primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia.
 Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2
 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5
 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6).
 Anticipated time on study treatment is 6 months, with a 30-month follow-up period.
Inclusion Criteria:

 -  Adult patients, >/= 65 years of age

 -  Previously untreated B-cell chronic lymphocytic leukemia (CLL)

 -  Binet stage C or active Binet stage A and B disease

 Exclusion Criteria:

 -  Prior treatment for CLL

 -  CLL with transformation (Richter's syndrome)

 -  Suspected or known central nervous system (CNS) involvement of CLL

 -  Impaired renal or hepatic function

 -  Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B
 Virus (HBV) surface antigen positive, or any active or uncontrolled infections

 -  Patients with anti-HBV core antibodies (past infection with HBV) but who are negative
 for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or
 negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain
 reaction (PCR) analysis

 -  Concomitant diseases requiring chronic steroid administration

 -  Active second malignancy within the 2 years prior to study (except for non-melanoma
 skin cancer and in situ cervix or breast or prostate carcinoma)

 -  Eastern Cooperative Oncology Group (ECOG) performance status >/= 3