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

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• 作者：Franck Morschhauser ; Olivier Fitoussi ; Corinne Haioun ; Catherine Thieblemont ; Hang Quach ; Richard Delarue ; Sylvie Glaisner ; Jean Gabarre ; Andr¨¦ Bosly ; John Lister ; Ju Li ; Bertr ; Coiffier
• 关键词：T-cell non-Hodgkin lymphoma ; Phase 2 ; EXPECT ; Lenalidomide
• 刊名：European Journal of Cancer
• 出版年：2013
• 出版时间：September, 2013
• 年：2013
• 卷：49
• 期：13
• 页码：2869-2876
• 全文大小：466 K

文摘

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 lenalidomide 25 mg once daily on days 1-21 of each 28-day cycle for a maximum of 24 months, until disease progression or development of unacceptable adverse events (AEs). The primary end-point was efficacy; safety was evaluated as a secondary end-point. This study was registered with ClinicalTrials.gov, number .

Findings

A total of 54 patients with PTCL were treated. The overall response rate was 22 % (12 of 54), including complete response (CR) or unconfirmed CR (CRu) in 11 % of patients; 31 % of patients with angioimmunoblastic T-cell lymphoma (AITL) responded (CR/CRu in 15 % of patients). The median progression-free survival and median response duration were 2.5 and 3.6 months, respectively, in the intent-to-treat population, and 4.6 and 3.5 months, respectively, in patients with AITL. Thrombocytopenia and neutropenia were the most common grade 3 or 4 haematological AEs, in 11 (20 % ) and 8 (15 % ) patients, respectively. Overall, 19 patients (35 % ) experienced at least 1 AE leading to study dose interruption or reduction (commonly neutropenia or thrombocytopenia). Serious AEs were observed in 54 % of patients and 12 patients died during the study; lymphoma progression (n = 6); and acute respiratory distress syndrome, dyspnea, lung infiltration, neutropenic sepsis, pneumonia and cerebral ischaemia (n = 1 each).

Interpretation

Lenalidomide exhibited single-agent activity in heavily pretreated patients with PTCL, particularly in patients with AITL. Future development is warranted in specific histologies, such as AITL, and in combination with chemotherapy or other agents considered active in PTCL.

Funding

Celgene Corporation.