Activity and Safety of Lenalidomide and Rituximab (LenRtx) as Non-chemotherapy Based Therapy for Patients With Chronic Lymphocytic Leukemia

  • participants needed
  • sponsor
    MD Anderson International Spain SA
Updated on 8 November 2020
chronic lymphocytic leukemia
monoclonal antibodies
monoclonal protein


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 development a non-cytotoxic and effective treatment for CLL that it 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.

Condition Chronic Lymphocytic Leukemia
Treatment Lenalidomida and Rituximab
Clinical Study IdentifierNCT01348815
SponsorMD Anderson International Spain SA
Last Modified on8 November 2020


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