title: Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma.
abstract: BACKGROUND
  Novel therapies are needed to improve outcomes in T-cell lymphomas. The authors report the interim results of a prospective multicenter trial evaluating lenalidomide in T-cell lymphomas.
  
  
  METHODS
  Patients with recurrent and refractory T-cell lymphomas other than mycosis fungoides and untreated patients ineligible for combination chemotherapy were prescribed oral lenalidomide (25 mg daily) on Days 1 to 21 of each 28-day cycle until disease progression, death, or unacceptable toxicity. The primary endpoint was overall response rate. Secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. The 2-stage design allows for up to 40 patients.
  
  
  RESULTS
  At the time of this interim analysis, 24 patients were enrolled in this study, and 23 were evaluable for response. The median age was 65 years. The overall response rate was 7 (30%) of 23; all were partial responses. Two patients had stable disease for ≥5 cycles. Responses were seen in anaplastic, angioimmunoblastic, and peripheral T-cell unspecified histologies. Median PFS was 96 days (range, 8-696+ days). Median OS was 241 days (range, 8-696+ days). The most common grade 4 adverse event was thrombocytopenia (33%). The most common grade 3 adverse events were neutropenia (21%), febrile neutropenia (17%), and pain not otherwise specified (17%). Rash correlated with response to therapy (P=.003).
  
  
  CONCLUSIONS
  In patients with recurrent and refractory T-cell lymphomas, oral lenalidomide monotherapy has clinical activity, and toxicity is consistent with the known safety profile of lenalidomide. Further study of lenalidomide in these diseases is warranted.
authors.affiliation: Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Greg
authors.initials: G
authors.lastname: Dueck
authors.forename: Neil
authors.initials: N
authors.lastname: Chua
authors.forename: Angeli
authors.initials: A
authors.lastname: Prasad
authors.forename: Daygen
authors.initials: D
authors.lastname: Finch
authors.forename: Doug
authors.initials: D
authors.lastname: Stewart
authors.forename: Darrell
authors.initials: D
authors.lastname: White
authors.forename: Richard
authors.initials: R
authors.lastname: van der Jagt
authors.forename: James
authors.initials: J
authors.lastname: Johnston
authors.forename: Andrew
authors.initials: A
authors.lastname: Belch
authors.forename: Tony
authors.initials: T
authors.lastname: Reiman
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D016399:Lymphoma, T-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide