Non Hodgkin Lymphoma Clinical Trial
Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. 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. Giving lenalidomide together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.
To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.
To determine the time to disease progression, duration of response, and overall survival of these patients.
To determine the tolerability of this regimen in these patients.
To assess changes in serum cytokines before and after treatment and correlate these changes with response.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not achieve complete response after 2 courses of rituximab may receive up to 4 additional doses of rituximab once weekly for 4 weeks.
Blood samples are collected at baseline and after treatment for cytokine analysis.
After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.
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
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
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)
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There is 1 Location for this study
Sacramento California, 95817, United States
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