In the last ten years there have been significant developments in CLL treatment. The advent
of fludarabine, rituximab and the association of chemo-immunotherapy have substantially
increased overall response rate, CR rate, time to progression and may also have an impact on
overall survival.
Even though, CLL remains incurable and all patients eventually relapse and progressively
become resistant to treatment. The development of an effective therapy that is not
cross-resistant with the ones currently available as front-line treatment, is one of the
clinical unmet needs within CLL.
BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of
bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.
Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating
agents and purine analogue properties that may lack of cross resistance with fludarabine. It
was utilized in CLL as a single agent and its association with rituximab is currently under
clinical investigation.
Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on
CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is
effective in highly pre-treated refractory CLL patients.
Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis
of these data, bendamustine and ofatumumab could be a new effective and well tolerated
combination for patients with relapsed and refractory CLL.