ARCTIC (FCR Vs FCM-miniR) Version 1.0

• Research type

  Research Study

• Full title

  ARCTIC: Attenuated dose Rituximab with ChemoTherapy In CLL. A randomised, phase IIB trial in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL) to compare fludarabine, cyclophosphamide and rituximab (FCR) with FC, mitoxantrone and low dose rituximab (FCM-miniR).

• IRAS ID

  9377

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2009-010998-20

• ISRCTN Number

  ISRCTN16544962

• 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 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. The current treatment for CLL usually involves two different chemotherapy drugsfluarabine and cyclophosphamine or FC for short) given together, every month for 6 months. Although most patients respond to FC, it cannot kill every CLL cell meaning that patients eventually relapse and need further treatment. Most patients who require treatment will eventually die of CLL and so more effective treatments are needed.Rituximab (R) is an antibody which targets CLL and works in a different way from chemotherapy. It seems that adding rituximab to chemotherapy results in more effective CLL cell killing, with more patients responding, and possibly increases the time until further treatment is required. However, evidence suggests that'sing a smaller dose of rituximab (mini R for short) may be just as effective as using the full dose usually used. Rituximab is given via a drip and so using a smaller dose would decrease the time the drip takes and may decrease any reactions the patient may have to the drug.Mitoxantrone (M) is a chemotherapy drug and evidence suggests that adding this to FC may also make the treatment more effective. It is therefore believed that treatment with FCM-miniR may be just as effective as treatment with FCR. This trial will recruit patients who have not had any treatment for their disease. It will assess the response of patients who are treated with FCR with the response of those treated with FCM-miniR. If the results of this trial are positive, a larger phase III trial is planned.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/54

• Date of REC Opinion

  25 Jun 2009

• REC opinion

  Further Information Favourable Opinion