FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving bendamustine together with rituximab in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared with bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: German CLL Study Group
• Collaborators: Mundipharma Pte Ltd.; Roche Pharma AG
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:

• Binet stage C disease or stage B or A disease requiring treatment

• Binet stage B or A disease meeting ≥ 1 of the following:

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

• Progressive lymphocytosis, defined as peripheral lymphocyte count > 5 x 10^9/L (i.e., > 50% increase over a 2-month period or doubling of peripheral blood lymphocyte count < 6 months)

• 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) or progressive or symptomatic lymphadenopathy

• No 17p deletion by FISH

• No aggressive B-cell cancer, such as Richter syndrome

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy ≥ 6 months

• Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless directly attributable to CLL)

• AST and ALT ≤ 2 times ULN (unless directly attributable to CLL)

• Creatinine clearance ≥ 70 mL/min (creatinine clearance is to be calculated only in patients with serum creatinine ≥ 1.1 mg/dL)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy

• Hepatitis B and C negative

• HIV negative

• CIRS score > 6 or a single score of 4 for one organ category

• No active secondary malignancy requiring treatment, except basal cell carcinoma or malignant tumor curatively treated by surgery, or successfully treated secondary malignancies in complete remission > 5 years prior to enrollment

• No history of anaphylaxis following exposure to monoclonal antibodies

• No active bacterial, viral, or fungal infection

• No medical condition requiring prolonged use of oral corticosteroids (i.e., > 1 month)

• No cerebral dysfunction or legal incapacity

• No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

• No prior CLL specific-chemotherapy, radiotherapy, and/or immunotherapy

• Prednisolone administered immediately prior to initiation of study therapy allowed for very high lymphocyte counts

• No concurrent participation in another clinical trial