A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial

摘要: Abstract Background This multicentre, single-arm, open-label phase 2 trial investigated the efficacy and safety of lenalidomide monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). Methods Patients received oral 25mg once daily on days 1–21 each 28-day cycle for a maximum 24months, until disease progression or development unacceptable adverse events (AEs). The primary end-point was efficacy; evaluated as secondary end-point. study registered ClinicalTrials.gov, number NCT00655668. Findings A total 54 PTCL were treated. overall response rate 22% (12 54), including complete (CR) unconfirmed CR (CRu) 11% patients; 31% angioimmunoblastic (AITL) responded (CR/CRu 15% patients). median progression-free survival duration 2.5 3.6months, respectively, intent-to-treat population, 4.6 3.5months, AITL. Thrombocytopenia neutropenia most common grade 3 4 haematological AEs, 11 (20%) 8 (15%) patients, respectively. Overall, 19 (35%) experienced at least 1AE leading to dose interruption reduction (commonly thrombocytopenia). Serious AEs observed 54% 12 died during study; ( n =6); acute respiratory distress syndrome, dyspnea, lung infiltration, neutropenic sepsis, pneumonia cerebral ischaemia =1 each). Interpretation Lenalidomide exhibited single-agent activity heavily pretreated PTCL, particularly Future is warranted specific histologies, such AITL, combination chemotherapy other agents considered active PTCL. Funding Celgene Corporation.