Lenalidomide maintenance in CTCL: Phase III v1.0

• Research type

  Research Study

• Full title

  A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy

• IRAS ID

  41081

• Contact name

  Sean Whittaker

• Contact email

  sean.whittaker@kcl.ac.uk

• Sponsor organisation

  EORTC - European Organisation for Research and Treatment of Cancer

• Eudract number

  2009-011020-65

• ISRCTN Number

  xx

• Research summary

  The objective of this study is to determine if maintenance treatment with lenalidomide prolongs progression free survival in patients with advanced stage cutaneous T-cell lymphoma that has not been previously treated with intravenous chemotherapy except the chemotherapy received in the preceding debulking stage as outlined in chapter one. Patients will be randomized to either receive the maintenance therapy or not, and these two study areas will be compared in terms of the difference in progression free survival.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/64

• Date of REC Opinion

  10 Nov 2010

• REC opinion

  Further Information Favourable Opinion