Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: German CLL Study Group
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

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