CyCLLe

• Research type

  Research Study

• Full title

  A phase II trial of Cyclosporin A in Early Adverse Risk CLL

• IRAS ID

  109704

• Contact name

  Stephen Devereux

• Eudract number

  2012-002795-13

• ISRCTN Number

  No number

• Clinicaltrials.gov Identifier

  No number

• Research summary

  The CyCLLe trial aims to measure the spontaneous proliferation (growth) rate of leukaemia cells in patients with Chronic Lymphocytic Leukaemia (CLL) and evaluate the effect of an immunosuppressive drug called Cyclosporin A (CsA), on the rate of proliferation. For the majority of patients, CLL is incurable and once the disease has progressed it can lead to chronic illness, reduced survival and poor quality of life. CLL progression occurs when there is an imbalance between the growth of new leukaemic cells and the rate of cell death. This trial will investigate a strategy for delaying the progression of CLL using CsA. Activated T-cells appear to perform an important role in tumour cell proliferation. As CsA is known to decrease T cell activation in tumour cells, it is possible it could reduce the rate of growth of new tumour cells and therefore delay disease progression.The trial will recruit 10 patients with early stage CLL, who do not currently require therapy, from 2 Trials Acceleration Programme (TAP) centres. The research is funded by Leukaemia and Lymphoma research. The rate of cell growth and loss of cells from the circulation will be assessed over 3 cycles (8 weeks apart) using deuterated (heavy) glucose. Patients will attend clinic on day 0 of each cycle to drink a sugar solution containing deuterated glucose and provide a blood sample. Patients will return on day 4 of each cycle for a further blood test to measure proliferation rates. Treatment will begin at week 13 for 8 weeks, continuing for an additional 4 months if a benefit is seen. Patients will be seen once/twice weekly whilst on treatment. Rates of release may also be measured in patients who consent to additional visits for extra blood samples. The maximum time the patient would be on study is 11 months.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  12/EE/0485

• Date of REC Opinion

  12 Dec 2012

• REC opinion

  Further Information Favourable Opinion