ADMIRE Trial Version 1.0

• Research type

  Research Study

• Full title

  ADMIRE: Does the Addition of Mitoxantrone Improve Response. A randomised, phase II trial of fludarabine, cyclophosphamide and rituximab (FCR) +/- mitoxantrone (M) in previously untreated chronic lymphocytic leukaemia.

• IRAS ID

  10986

• Sponsor organisation

  THE LEEDS TEACHING HOSPITALS NHS TRUST

• Eudract number

  2008-006342-25

• ISRCTN Number

  42165735

• Research summary

  Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia affecting 6 in 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, failure of the bone marrow to make normal blood cells due to replacement with CLL, infections, severe tiredness, weight loss and sweating. The current treatment for CLL usually involves two different chemotherapy drugsfluarabine and cyclophosphamide or ??FC?) given together, every month for 6 months. Although most patients respond to FC, the chemotherapy is not able to kill every CLL cell meaning that patients eventually relapse and require further treatment. The time until relapse depends on the depth of remission. Most patients who require therapy will eventually die of CLL and so more effective treatments are urgently needed.Rituximab is an antibody which targets CLL cells and works in a different way to chemotherapy. It appears that combining rituximab with chemotherapy results in more effective CLL cell killing, with more patients responding and possibly prolonging the time until further treatment. Mitoxantrone (M) is a chemotherapy drug and recent evidence suggests that adding this drug to the FC combination may also improve the effectiveness of treatment.This trial will recruit patients who have not yet received any treatment for their disease. It will assess the response of patients who are treated witfluarabine, cyclophosphamide and rituximab (FCR) compared with the response of patients who receivfluarabine, cyclophosphamide, rituximab and mitoxantrone (FCM-R). If it appears that there is a difference in response between the two treatment groups, then a large trial is planned which will compare the time taken for disease progression to occur between the two treatment groups.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  08/H1307/135

• Date of REC Opinion

  9 Feb 2009

• REC opinion

  Further Information Favourable Opinion