BO21004 - RO5072759 Safety and Efficacy Chemo Combo in untreated CLL

• Research type

  Research Study

• Full title

  An open-label, multi centre, three arm randomised, phase III study to investigate the efficacy and safety of R05072759 + chlorambucil (GClb), rituximab and chlorambucil (RClb) or chlorambucil (Clb) alone in previously untreated CLL patients with co-morbidities.

• IRAS ID

  24440

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-012476-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Chronic Lymphocytic Leukaemia is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which play a key role in the body's defence system. These altered B-cells are unable to function properly, and as their multiplication takes over that of their healthy counterparts, the body's ability to fight infection is compromised. Currently immunochemotherapy witfluarabine, cyclophosphamide and rituxumab (FCR) is the standard of care in 1st line CLL patients. However it is important to recognise that favourable outcome of FCR treatment has been reported only for patients not suffering from other medical impairments i.e. major co-morbidities, organ dysfunction and low performance status, for which FCR can potentially facilitate the occurrence of these conditions. Patients considered to be ineligible fofluarabine based immunochemotherapy are generally treated with chlorambucil and although well tolerated, complete responses are rare. In the medically unfit, trial data that convincingly demonstrates superiority of modern treatment approaches to chlorambucil are currently lacking. Specifically, the combination of chlorambucil as a standard of care in such patients with CD20 antibodies warrants further exploration. RO5072759 is a new monoclonal antibody (a molecule that fights infection and foreign cells). Like rituximab, RO5072759 works by targeting a specific protein, CD20, found on the surface of both healthy and cancerous B-cells and then destroying them. The body will produce new healthy cells to replace the ones that have been killed during treatment. This study aims to find out if this new antibody added to chlorambucil, is more effective at treating CLL, compared to chlorambucil treatment alone and chlorambucil given in combination with rituximab. Eligible patients will receive up to a maximum of 6 cycles of treatment. Each cycle will last a minimum of 28 days.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/55

• Date of REC Opinion

  28 Oct 2009

• REC opinion

  Further Information Favourable Opinion