Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients

Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.

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.