Rituximab added to levact or chlorambucil in patients with CLL

• Research type

  Research Study

• Full title

  A randomized Phase IIIb study of MabThera ® (rituximab) added to a chemotherapy, levact or chlorambucil, in patients with Chronic Lymphocytic Leukemia

• IRAS ID

  27433

• Contact name

  Anna Schuh

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  2009-012072-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  RiBECCA (Protocol No. MO22468) is a research study in which patients with chronic lymphocytic leukaemia (CLL - a cancer of the white blood cells) will receive one of 2 treatments. Patients will receive rituximab plus bendamustine or rituximab plus chlorambucil. The study will be conducted in newly diagnosed patients (first line) or patients who have had a maximum of 1 line of previous treatment (second line). The purpose of the study is to compare the response (Complete Response rate - CR rate) between the two treatments after 6 cycles (courses) of treatment for all the patients both first and second line CLL to determine which is the most effective. 660 patients will receive at least 1 cycle of treatment. There will be 330 patients in each treatment group with equal numbers of first and second line patients in each group. Patients will be recruited from approximately 100 centres in Europe and Canada with 50 patients being recruited in the UK at 8-10 hospitals. Overall, a patient can be in the study for up to 48 months and they will be seen regularly to assess their response to treatment. The study duration includes about 1 month for screening followed by a treatment period of up to 12 months (= up to 12 cycles) for the patients who receive rituximab (6 cycles only) plus chlorambucil (If the patient has not responded they may be treated with a further 6 cycles of chlorambucil alone). For those patients who receive rituximab plus bendamustine the treatment period is up to 6 months (equates to 6 cycles). Confirmation of response will take place about 8 weeks after initial diagnosis of CR. Patients will be followed up for 12 to 42 months until the cut-off date for the study which is expected to be 3rd quarter 2013.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/101

• Date of REC Opinion

  5 Oct 2009

• REC opinion

  Favourable Opinion