Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I Study of the Activity and Safety of Lenalidomide and Rituximab as Non-chemotherapy Therapy for Patients With Recurrent and Refractory Chronic Lymphocytic Leukemia
The rationale for combining lenalidomide with rituximab derives from preclinical
observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular
cytotoxicity) triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK
cytotoxicity by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These
results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant
in immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The
combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on
CLL cell lines. However the observed synergism was attributed to NK cells expansion, thus
lending support to the notion that this synergism may operate in other B-cell
lymphoproliferative malignancies.
The objective was to develop a non-cytotoxic and effective treatment for CLL that would
fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and
frail. These patients experience an excess in chemotherapy induced toxicity, often
preventing the completion of the planned treatment.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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