Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Inclusion Criteria

• •Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes:
• •* Follicular lymphoma:
• •* Grade I follicular small cleaved cell;
• •* Grade II follicular mixed cell;
• •* Grade II follicular large cell;
• •* Diffuse small cleaved cell;
• •* Small lymphocytic lymphoma;
• •* Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)
• •AND
• •* Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue \[MALT\] lymphoma);
• •* Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma);
• •* Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes);
• •* Mantle cell lymphoma:
• •* No blastic phase mantle cell lymphoma
• •Relapsed or refractory, progressive disease:
• •* First, second, or third relapse
• •Measurable disease, meeting 1 of the following criteria:
• •* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan (for NHL patients);
• •OR:
• •* Lymphocytosis \> 50,000/mm3 OR evidence of progressive bone marrow infiltration failure (e.g., hemoglobin 10 g/dL) OR thrombocytopenia (i.e., platelet count \< 100,000/mm3) with \> 30% infiltration of bone marrow by leukemia (for CLL patients)
• •No measurable lymphadenopathy (for CLL and Waldenstrom's macroglobulinemia patients)
• •No evidence of CNS lymphoma
• •Performance status:
• •* ECOG 0-2
• •Life expectancy:
• •* More than 12 weeks
• •No history of uncontrolled orthostatic hypotension
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •HIV negative
• •No uncontrolled concurrent illness
• •No grade 2 or greater neuropathy
• •No history of allergy or anaphylaxis to mannitol, bortezomib, fludarabine, or boron
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study compliance
• •At least 4 weeks since prior monoclonal antibody (MoAB) therapy:
• •* Patients who have received MoAB therapy within the past 3 months must have documented disease progression since receiving this therapy
• •No prior allogeneic stem cell transplantation
• •More than 4 weeks since prior chemotherapy
• •Prior fludarabine allowed
• •At least 1 week since prior steroids
• •At least 3 months since prior radio-immunotherapy
• •More than 4 weeks since prior radiotherapy
• •No prior bortezomib
• •Absolute neutrophil count at least 1,500/mm3
• •Platelet count at least 75,000/mm3 (greater than 50,000/mm3 if lymphomatous bone marrow involvement is present)
• •Bilirubin no greater than 2.0 mg/dL
• •AST/ALT no greater than 4 times normal
• •Creatinine clearance greater than 40 mL/min
• •No other concurrent investigational agents or treatments for the malignancy
• •No brain metastases
• •OR:
• •Quantitation of IgM paraprotein (for Waldenstrom's macroglobulinemia patients)