The "SPRINT" trial. A phase 2 study on the efficacy of Lenalidomide.

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Open-Label study to determine the Efficacy of Lenalidomide (Revlimid®) versus Investigator’s choice in patients with relapsed or refractory Mantle Cell Lymphoma.

• IRAS ID

  12439

• Sponsor organisation

  Celgene International

• Eudract number

  2008-003389-25

• Clinicaltrials.gov Identifier

  00875667

• Research summary

  This study is being conducted to investigate a new drug, called Lenalidomide, in patients with mantle cell lymphoma (a type of cancer of the lymph nodes that affects the white blood cells) who have relapsed after initial therapy. For patients with this disease the prognosis is poor and there is no clear consensus on how such patients should be treated. Relapses occur eventually in most patients and despite initial responses, the remission durations are short. There is therefore a clear need for novel innovative approaches and it is hoped that this study will help to determine if Lenalidomide is an effective treatment in patients who have relapsed after 1 and up to 3 prior chemotherapy regimens. Primarily this will be done by measuring the extent of tumor shrinkage (called tumor response) to Lenalidomide. A total of approximately 200 patients will be screened for enrollment into this study from 14 different countries in Europe. Approximately 150 patients will be randomized, 100 of these patients will receive the study drug, Lenalidomide, and 50 will be part of the control arm of the study and receive a single agent of the Investigators choice. Patients will be randomly assigned to a group in a 2:1 fashion and will be aware of what arm of the study they are on. Patients in the control arm will have the option to switch onto the study drug if their disease progresses. This study is due to last for up to 4 years. Patients will continue to receive treatment as long as the study drug helps and they do not experience side effects that cannot be controlled or if the patients voluntarily decides to stop study drug treatment. This study is sponsored by Celgene Corporation.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/39

• Date of REC Opinion

  2 Jun 2009

• REC opinion

  Further Information Favourable Opinion