Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to
 see how well they work compared to fludarabine and cyclophosphamide in treating patients with
 B-cell chronic lymphocytic leukemia.
DISEASE CHARACTERISTICS:

 -  Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer
 Institute (NCI) Working Group criteria

 -  Meets 1 of the following criteria:

 -  Binet stage C disease

 -  Binet stage B disease AND ≥ 1 of the following signs or symptoms*:

 -  B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months,
 fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or
 constitutional symptoms (fatigue)

 -  Continuous progression (doubling of peripheral lymphocyte count within the
 past 6 months and absolute lymphocyte count > 50 G/I)

 -  Evidence of progressive marrow failure as manifested by the
 development/worsening of anemia and/or thrombocytopenia

 -  Massive, progressive or painful splenomegaly or hypersplenism

 -  Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter),
 danger of organ complications through large lymphoma (e.g., vascular
 compression or tracheal narrowing), or progressive lymphadenopathy

 -  Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200
 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the
 development of a monoclonal protein in the absence of any of the above
 criteria for active disease is not sufficient for eligibility

 -  No Binet stage A disease

 -  No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell
 lymphoma, Richter's syndrome, or prolymphocytic leukemia)

 PATIENT CHARACTERISTICS:

 -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

 -  Cumulative Illness Rating Scale (CIRS) score > 6

 -  Life expectancy > 6 months

 -  Bilirubin ≤ 2 times upper limit of normal (ULN)

 -  Alkaline phosphatase and transaminases ≤ 2 times ULN

 -  Creatinine clearance ≥ 70 mL/min

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception during and for 2 months after study
 treatment

 -  No known hypersensitivity with anaphylactic reaction to humanized monoclonal
 antibodies or any of the study drugs

 -  No cerebral dysfunction that precludes chemotherapy

 -  No active bacterial, viral, or fungal infection

 -  No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia

 -  No other active malignancy requiring concurrent treatment except basal cell carcinoma
 or tumors treated curatively by surgery

 -  No medical or psychological condition that would preclude study therapy

 -  No concurrent disease that requires prolonged (> 1 month) therapy involving
 glucocorticoids

 PRIOR CONCURRENT THERAPY:

 -  No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy