A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; Rituximab
Intervention description: Participants received cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle.; Participants received fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle.; Participants received 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This multi-center, single-arm study evaluated the efficacy and safety of rituximab in
      combination with fludarabine and cyclophosphamide in participants with B-cell chronic
      lymphocytic leukemia (CLL) and favorable somatic status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically

          -  For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity
             score less than or equal to (</=) 6

          -  Binet stage B, C or A with progression

          -  Life expectancy greater than or equal to (>/=) 12 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

          -  Women of child bearing potential and men should agree to use highly reliable
             contraceptive method throughout the treatment period and within 12 months after
             treatment completion

        Exclusion Criteria:

          -  Participants with small-cell lymphoma

          -  Participants with auto-immune hemolytic anemia

          -  Concomitant malignant disease during enrollment, except basal cell carcinoma of the
             skin

          -  Chemotherapy for concomitant malignant disease given within 12 months prior to study
             enrollment

          -  Participants with Richter's Syndrome

          -  Participants with symptomatic Hepatitis B infection

          -  Any clinically significant infection that could not be cured prior to enrollment,
             including Human Immunodeficiency Virus (HIV) infection

          -  Creatinine clearance less than (<) 30 milliliters per minute (mL/min)

          -  Participants with congestive heart failure (CHF) New York Heart Association (NYHA)
             III-IV

          -  Participants with liver failure and acute hepatitis of any etiology

          -  Any other medical or mental condition which may preclude from receiving the entire
             course of protocol specified treatment or signing the informed consent

          -  History of an anaphylactic reaction to murine antibodies, proteins, or any other
             ingredient of rituximab

          -  Pregnancy and breast-feeding women