Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory
or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy
is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no
ASCT is possible due to progressive disease. For these patients or ineligible to
transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine regimen
with an overall response rate (ORR) about 50%.
Bendamustine in combination with rituximab, used as a single agent in the setting of R/R
DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.
Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell
lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine with
Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were previously
untreated, refractory or relapsed was evaluated.
The efficacy and safety of the R-BAC association will be evaluated in this phase II trial
enrolling 78 patients with relapsed or refractory DLBCL.