Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):
• * Absolute lymphocytosis \> 5,000/mm\^3
• * Lymphocytes must appear mature with \< 55% prolymphocytes
• * More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear
• * Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy
• * Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping
• High-risk disease OR intermediate-risk disease
• * Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:
• * Massive or progressive splenomegaly and/or adenopathy
• * Weight loss \> 10% within the past 6 months
• * Common toxicity grade 2-4 fatigue
• * Fevers \> 100.5°F OR night sweats for more than 2 weeks without evidence of infection
• * Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of \< 6 months
• Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:
• * Refractory or intolerant to fludarabine
• * Relapsed within 6 months after completion of fludarabine
• No CNS leukemia
• No mantle cell lymphoma in leukemic phase
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Zubrod 0-2
• Life expectancy
• More than 2 months
• Hematopoietic
• Absolute neutrophil count ≥ 1,000/mm\^3
• Platelet count ≥ 50,000/mm\^3
• Hemoglobin ≥ 8 g/dL (transfusion allowed)
• Hepatic
• Albumin ≥ 3 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• No hepatitis B or C infection
• Renal
• Creatinine ≤ 1.5 mg/dL OR
• Creatinine clearance ≥ 40 mL/min
• Cardiovascular
• LVEF ≥ 40%
• Other
• No uncontrolled infection
• No other concurrent serious illness
• No HIV infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Prior denileukin diftitox allowed
• Chemotherapy
• See Disease Characteristics
• Endocrine therapy
• No concurrent corticosteroids as anti-emetics
• Radiotherapy
• No concurrent radiotherapy
• Surgery
• Not specified
• Other
• At least 28 days since prior anticancer therapy and recovered
• No other concurrent antineoplastic drugs