Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or… (NCT01145495) | Clinical Trial Compass
CompletedPhase 2
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
United States66 participantsStarted 2010-06-15
Plain-language summary
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (\> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass \>= 7 cm in any uni-dimensional measurement) stage II
* Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable for diagnosis
* Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
* Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression
* Low or intermediate risk by Follicular Lymphoma International Prognostic Index (FLIPI): 0-2 risk factors
* No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy); patients may have received involved-field radiation therapy
* No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass \> 1 cm is acceptable
* Lesions that are considered non-measurable include the following:
* Bone lesions (lesions if present …
What they're measuring
1
Number of Participants Who Achieved a Complete Response