Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
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.