CLL210 (CamDexRev)

• Research type

  Research Study

• Full title

  Phase II trial of ofatumumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (NCRI CLL210)

• IRAS ID

  56135

• Contact name

  Andrew Pettitt

• Sponsor organisation

  University of Liverpool

• Eudract number

  2010-019575-29

• ISRCTN Number

  to be applied

• Research summary

  This phase II open label multicentre randomised clinical trial will investigate around 85 patients with high risk Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) who are unlikely to respond well to conventional therapy because they have already failed such therapy or because of an abnormality in a gene called p53 that makes them very likely to fail it. This type of CLL is ??high-risk? owing to the difficulty of treating it effectively. The trial will be run across approximately 20 centres throughout the United Kingdom. During the induction period of 24 weeks, enrolled patients are treated with Alemtuzumab, Dexamethasone and Lenalidomide (CamDexRev) together with six drugs to reduce side effects. CamDexRev is hoped to be more effective than current treatments. It is anticipated that 25% of patients who demonstrate a response to induction therapy will undergo allogeneic stem-cell transplantation. The remainder (aiming for 54 in total) will be randomised to receive a) continued treatment with Lenalidomide, or b) no further treatment. The primary aims are;?½ INDUCTION: assess the Complete Response rate in patients who have received 6 months of induction therapy. ?½ MAINTENANCE: assess the progression-free rate after 2 years of maintenance therapy. Patients who are randomised to receive Lenalidomide therapy will receive treatment until disease progression or until discontinuation. Patients not responding to induction therapy or have progressive disease after induction therapy are followed up every two months.Treatment schedule:?½ Throughout induction phase: clinical assessment is weekly. ?½ During maintenance phase: patients will be required to attend for clinical assessment every two weeks for the first two months, then every four weeks for the next two months, then every two months. ?½ Patients randomised to receive no treatment will be assessed every 2 months throughout remission. All laboratory and physical assessments are routine for CLL but additional scientific tests may be performed when specific consent has been given.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/H1005/10

• Date of REC Opinion

  11 Apr 2011

• REC opinion

  Further Information Favourable Opinion