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

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Lenalidomide; Thalidomide

Criteria

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.