Study of ofatumumab plus chlorambucil in previously untreated CLL: v01

• Research type

  Research Study

• Full title

  Study OMB110911. A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil Monotherapy in previously untreated patients with Chronic Lymphocytic Leukemia

• IRAS ID

  5947

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2008-004932-19

• ISRCTN Number

  n/a

• Research summary

  The primary objective of this study is to compare the time from first receiving study treatment until disease progression or death (progression-free survival) of subjects taking ofatumumab (a new monoclonal antibody which targets Chronic Lymphocytic Leukaemia cells) added to chlorambucil (a chemotherapy of the alkylating agent class) with subjects taking chlorambucil alone for the treatment of previously untreated (front line) Chronic Lymphocytic Leukaemia (CLL). Chlorambucil is a therapy currently approved for frontline treatment of CLL. The addition of ofatumumab to chlorambucil is being investigated in this open-label randomised study, to see if it offers a more effective therapy with limited additional toxicities. Secondary objectives include an evaluation of subjects' overall well-being and quality of life.Approximately 444 eligible subjects, at least 101 in the UK, will be stratified and randomised in a 1:1 ratio to receive either ofatumumab as monthly iv infusions (300mg on day 1 and 1000mg on day 8 of cycle 1; 1000mg on day 1 of subsequent 28-day cycles) together with oral chlorambucil (10mg/m2 on Days 1-7 of each 28-day cycle) or the same dose of oral chlorambucil alone. All subjects will receive 3 cycles of treatment and their disease will be assessed. Dependent on a subject's response, they may receive further treatment up to a maximum of 12 cycles.Subjects' response will be measured by blood samples, lymph node examination, spleen and liver measurement and assessment of clinical symptoms performed monthly throughout the treatment phase and at one month post treatment and then every 3 months for up to 5 years. A bone marrow examination and CT scan will be performed to confirm complete remission at least 3 months after end of treatment.Safety assessments will be performed on a regular basis including haematology, biochemistry and adverse events.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/7

• Date of REC Opinion

  27 Mar 2009

• REC opinion

  Further Information Favourable Opinion