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

Inclusion Criteria

• •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