title: 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.
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 lenalidomide 25mg 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 NCT00655668.
  
  
  RESULTS
  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 1AE 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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Celgene Corporation.
authors.affiliation: Department of Hematology, Hôpital Claude Huriez, Lille, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Olivier
authors.initials: O
authors.lastname: Fitoussi
authors.forename: Corinne
authors.initials: C
authors.lastname: Haioun
authors.forename: Catherine
authors.initials: C
authors.lastname: Thieblemont
authors.forename: Hang
authors.initials: H
authors.lastname: Quach
authors.forename: Richard
authors.initials: R
authors.lastname: Delarue
authors.forename: Sylvie
authors.initials: S
authors.lastname: Glaisner
authors.forename: Jean
authors.initials: J
authors.lastname: Gabarre
authors.forename: André
authors.initials: A
authors.lastname: Bosly
authors.forename: John
authors.initials: J
authors.lastname: Lister
authors.forename: Ju
authors.initials: J
authors.lastname: Li
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005060:Europe; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D007155:Immunologic Factors; D013792:Thalidomide; D000077269:Lenalidomide
keywords: EXPECT; Lenalidomide; Phase 2; T-cell non-Hodgkin lymphoma