Status:
TERMINATED
Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Celgene
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab. Secondary ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00848328
Start Date
August 25 2008
End Date
April 15 2024
Last Update
April 24 2025
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817