BO21000 Phase Ib GA101 Safety & efficacy Chemo Combo in B-cell fNHL

• Research type

  Research Study

• Full title

  An open-label, multi-centre, randomised, phase Ib study to investigate the safety and efficacy of RO5072759 given in combination with CHOP or FC chemotherapy in patients with CD20+ relapsed/refractory B-cell follicular non-Hodgkin’s lymphoma.

• IRAS ID

  5576

• Sponsor organisation

  F Hoffmann−La Roche AG

• Eudract number

  2008-001643-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Follicular Lymphoma is the most common type of slow growing Non-Hodgkin's lymphoma (a disease of the lymphatic system when a particular white blood cell called a lymphocyte becomes cancerous) often causes very few symptoms in the early stage, the most common is a painless lump or swelling in the neck, armpit or groin. Patients with low-grade or follicular NHL may achieve remission with conventional chemotherapy, however, these agents have had limited impact on survival with 50% of the patients dying within 5 years of first relapse. Currently, rituximab in combination with chemotherapy, represents the therapeutic option of choice for symptomatic patients with advanced follicular lymphoma.RO5072759 is a very similar to rituximab and share the same target and in general both drugs share common mechanisms of action the extent to which each mechanism contributes to efficacy and hence safety is thought to be different. These differences may result in increased or different side effects as RO5072759 kills off more of the cancerous cells as well as normal cells. RO5072759 is is being studied and funded by Roche Products Limited (Roche) to find out as much as possible about RO5072759 in combination with chemotherapy (a combination of drugs used to kill cancer cells) for treating patients with follicular non-Hodgkin??s lymphoma to see if there is an improved tumour response and slower progression of disease.Eligible patients will receive either up to a maximum of 6 Cycles of RO5072759 FC (given 4 weekly) or up to a maximum of 8 Cycles of RO5072759 CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) (given 3 weekly)5 Hospitals in the UK, King??s College Hospital, Southampton General Hospital, Derriford Hospital, Leicester Royal Infirmary & The Christie Hospital will be recruiting patients into the study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  08/H0703/132

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Further Information Favourable Opinion