Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.