COMPLEMENT A + B:

• Research type

  Research Study

• Full title

  A Randomised, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

• IRAS ID

  108188

• Contact name

  Simon Rule

• Eudract number

  2008-004177-17

• ISRCTN Number

  n/a

• Research summary

  Most patients with slow-growing lymphomas present with late stage (III or IV) disease and eventually require treatment. Slow-growing lymphomas are sensitive to alkylating agents and to combinations with biologics initially, but subsequently follow a pattern of multiple relapses and progressively shorter periods of remission between relapses. Options are limited after failure on Rituximab-containing regimens. OMB110918 is a randomised, open label, two arm, Phase III global study to test whether the combination of ofatumumab and bendamustine therapy lengthens the time during which the disease does not get any worse in patients with indolent B cell NHL that did not respond to Rituximab /Rituximab-containing regimen during or within 6 months of the last Rituximab treatment. Following a screening period, eligible patients will be randomised in a 1:1 ratio to one of two arms. Arm A will receive up to 8 cycles of bendamustine (90mg/m2) in combination with 12 doses of ofatumumab (1000mg). After completion of bendamustine, ofatumumab will be given monthly until all 12 doses are completed. Patients randomised to Arm B will receive up to 8 cycles of bendamustine (120mg/m2) alone. Ofatumumab will be offered to those in arm B with progressive disease (PD) confirmed by a scan. If patients choose to receive ofatumumab, therapy must begin =120 days following PD with 1000mg Ofatumumab for the first infusion on Week 1 followed by 2000mg weeks 2-4 and then once every month for 8 infusions i.e. a total of 12 doses. Patients from both arms will then be followed up for the disease free /overall survival aspects of the study starting on day 336, then every 3 months for 1.5 years, and every 12 months for 3.5 years. The study will enrol 346 patients overall, a minimum of 15 from the UK.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0394

• Date of REC Opinion

  17 Oct 2012

• REC opinion

  Further Information Favourable Opinion