LEGEND

• Research type

  Research Study

• Full title

  A randomised phase II study comparing LEnalidomide plus rituximab, GEmcitabine and methylprednisolone (LR-GEM) to rituximab, gemcitabine, methylprednisolone and cisplatiN (R-GEM-P) in second-line treatment of Diffuse Large B-cell lymphoma (DLBCL)

• IRAS ID

  112000

• Contact name

  David Cunningham

• Sponsor organisation

  The Royal Marsden NHS Foundation Trust

• Eudract number

  2012-002620-32

• ISRCTN Number

  xx

• Research summary

  Diffuse large B-cell lymphoma is the most common form of adult lymphoma (30-40% of adult lymphoma). It is one of the more aggressive forms of lymphoma but responds well to drug treatments such as chemotherapy and rituximab (an immune therapy). Despite this, in approximately one third of patients, lymphoma will relapse or be refractory to the first treatment with chemoimmunotherapy (in almost all cases this is R-CHOP), and for these patients, less than 50% will survive beyond 3 years. Therefore there is a need to improve the treatments given to patients with relapsed or refractory DLBCL. There is no current standard treatment regimen for patients in this setting, with commonly used regimens in the UK and internationally being combinations of chemotherapy Gem-P, DHAP, ESHAP, and ICE, usually given with rituximab. These regimens are intensive, necessitating at least overnight hospital stays, and associated with many side-effects including risk of hearing loss, nerve damage and kidney damage. In medically fit suitable patients, the treatment is followed by high-dose chemotherapy and an autologous stem cell (bone marrow) transplant. Lenalidomide is a novel oral immunomodulatory drug that shows encouraging effectiveness in DLBCL and has been safely combined with chemotherapy and gemcitabine in other cancer types. LEGEND is a study investigating whether lenalidomide in combination with gemcitabine, methylprednisolone and rituximab (LR-GEM) is more effective than the standard treatment of gemcitabine, methylprednisolone, cisplatin and rituximab (R-GEM-P, in patients with relapsed or refractory DLBCL. The primary endpoint is comparison of the complete response rate to 3 cycles of treatment. The study is planned to be carried out in multiple UK centres, with a maximum of 92 patients to participate.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/0108

• Date of REC Opinion

  2 Apr 2013

• REC opinion

  Further Information Favourable Opinion