Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically\* confirmed non-Hodgkin lymphoma, including one of the following subtypes:
• •* Grade 1, 2, or 3a (\> 15 centroblasts per high-power field with centrocytes present) follicular lymphoma according to WHO criteria
• •* Small lymphocytic lymphoma
• •NOTE: \*Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies; fine-needle aspirates are not acceptable for diagnosis.
• •At least one measurable lesion according to RECIST criteria
• •* Measurable lymphadenopathy to follow with serial exam and/or imaging
• •Relapsed or refractory disease
• •* Must have evidence of disease progression during or after last treatment
• •* If previously treated with rituximab, must have disease progression within 6 months of last therapy OR if there was a prior response to rituximab, rituximab must not have been given within the past 6 months
• •No evidence of CNS metastases
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy \> 3 months
• •Absolute neutrophil count ≥ 1,000/mm³
• •Platelet count ≥ 75,000/mm³
• •Serum creatinine ≤ 2.0 mg/dL
• •Total bilirubin ≤ 2.0 mg/dL
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective double method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
• •HIV negative
• •Able to swallow lenalidomide
• •Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation
• •No neuropathy ≥ grade 2
• •No known active hepatitis A, B, or C
• •No other malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• •No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude the patient from signing the informed consent form
• •No condition, including the presence of laboratory abnormalities, that would preclude study participation or confound the ability to interpret study data
• •No known hypersensitivity to thalidomide or rituximab
• •No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery
• •More than 28 days since prior experimental drug or therapy
• •No prior lenalidomide
• •No other concurrent anticancer agents or treatments, including radiotherapy or thalidomide
• •No other concurrent investigational agents
• •No concurrent sargramostim (GM-CSF)
• •No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)