COSMIC Version 1.0

• Research type

  Research Study

• Full title

  Combination FC plus Ofatumumab at Standard or Mega dose In CLL

• IRAS ID

  76052

• Contact name

  Peter Hillmen

• Sponsor organisation

  The Leeds Teaching Hospitals NHS Trust

• Eudract number

  2011-000796-14

• ISRCTN Number

  n/a

• Research summary

  Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia, affecting approximately 5 in every 100,000 people per year in the UK. In CLL the lymphocytes, a type of blood cell, become 'cancerous' and grow out of control. Patients with CLL develop very large lymph glands, high lymphocyte counts in the blood, and their bone marrow fails to make normal blood cells; they suffer from infections, severe tiredness, weight loss and sweating. Although the treatment of CLL has improved over recent years, the treatment of relapsed and refractory (not responsive to standard treatment) CLL remains difficult. The choice of treatment for relapsed CLL depends on various factors such as previous treatment, length of remission, age and performance status of the patient, stage of the disease and the biological characters of the malignant cellfluarabine and Cyclophosphamide (FC) are two chemotherapy drugs that together have proved to be effective at treating CLL. Ofatumumab is an antibody which targets CLL and works in a different way from chemotherapy. It is found to be effective on its own to a certain extent in treating refractory CLL. However, it is thought that adding Ofatumumab to chemotherapy (such as F and C) may improve response rates, although the best dose to be given is not known.This trial will recruit previously treated CLL patients who now require further treatment. It will assess the responses of patients who are treated with F and C combined with a standard dose of ofatumumab and the responses of those treated with F and C combined with a high dose of ofatumumab.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0260

• Date of REC Opinion

  24 Oct 2011

• REC opinion

  Further Information Favourable Opinion