Immunomodulatory drugs in chronic lymphocytic leukemia: a new treatment paradigm.

Immunomodulating drugs belong to a new class of therapeutic agents that have immunomodulatory, antiangiogenic and antiproliferative effects. Although the basis of anti-tumour activity of immunomodulating agents are not clear, results of clinical trials have demonstrated impressive activity in certain hemalogical disorders such as multiple myeloma (MM) and myelodysplastic syndromes (MDS). The peculiar properties of immunomodulating agents prompted investigators to test their role in patients with chronic lymphocytic leukemia (CLL). The efficacy of single-agent thalidomide in refractory CLL is disappointing, although its combination with fludarabine seems promising. Lenalidomide, a thalidomide analogue, is showing anti-tumour activity with durable response in refractory CLL. These preliminary results represent the basis for investigating the potential of lenalidomide in association with established chemotherapy regimens or as maintenance therapy.