CLARET Version 1.0

• Research type

  Research Study

• Full title

  CLARET: CLL Levels following Alemtuzumab in Responders to Early Therapy: A randomised, phase III trial to assess alemtuzumab consolidation therapy in patients with chronic lymphocytic leukaemia (CLL) who have responded to previous therapy.

• IRAS ID

  1551

• Contact name

  Peter Hillmen

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2008-003012-35

• ISRCTN Number

  ISRCTN63375144

• Research summary

  This study will recruit patients with chronic lymphocytic leukaemia (CLL) who have already received treatment and have responded well to this treatment. The study aims to assess the effect of treating this group of patients with a drug known as alemtuzumab. The study will compare treatment with alemtuzumab against no treatment. No treatment is the normal course of action at this stage of the disease. In particular the study will assess whether or not treatment with alemtuzumab has a different effect to no treatment on the length of time until CLL starts to increase again. The study will also assess the following: ?½ How well patients respond to treatment measured by the number of patients with complete or partial remission ?½ Whether or not treatment with alemtuzumab helps increase life span compared to no treatment. ?½ Whether alemtuzumab is able to remove CLL cells so that it can no longer be detected. This is known as minimal residual disease (MRD) negative. The study will assess how long the CLL cells can be removed for and if CLL cells can be removed below the level of detectability this has an effect on the time taken for CLL cells to increase again and if this also has an effect on life span. ?½ The side effects of treating patients with alemzutumab ?½ Finally the study will compare whether or not treatment with alemtuzumab effects a patients Quality of Life (QoL) in comparison to no treatment. To enter the study the level of CLL in the patients blood will be measured. Patients will then follow one of 3 pathways: ?½ Patients whose CLL is not detectable (MRD negative) will be followed up every 3 months for 3 years and then every year for the rest of their lives. ?½ Patients whose CLL is detectable (MRD positive) within 12 months since receiving their previous treatment for CLL will be eligible to proceed further and will be randomly allocated to receive either treatment with alemtuzumab or no treatment. o Patients allocated to no treatment will also be followed up every 3 months for 3 years and then every year for the rest of their lives. o Patients allocated to receive treatment will receive between 6 and 12 weeks of treatment which will be given by injection under the skin. Patients will then be followed regularly for the first 12 weeks following treatment and then every 3 months for 3 years and then every year for the rest of their lives.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/24

• Date of REC Opinion

  1 Jun 2010

• REC opinion

  Favourable Opinion