Lead Sponsor

University of Bologna

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Patients with histologic diagnosis of PTCL according to the WHO-REAL classification;
•Age \> 18 years;
•Relapsed (³1) or refractory to conventional chemotherapy/radiotherapy;
•Stage I-IV according to the Ann Arbor staging System;
•Performance status \<2;
•Adequate bone marrow reserve: platelets \>50 x 10(9)/L, absolute neutrophil count
•(ANC) \> 1.0 x 10(9)/L, hemoglobin \>8 g/d;
•Normal renal and hepatic functions;
•Negative HIV, HCV, and HBV status;
•Informed consent prior to registration on study

•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to thalidomide.
•The development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs.
•Any prior use of lenalidomide.
•Concurrent use of other anti-cancer agents or treatments.
•Known positive for HIV or infectious hepatitis, type A, B or C.

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