Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone Followed by Ibrutinib Maintenance in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non Candidates to ASCT
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maitenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
The use of highly effective rituximab-containing therapy for treating diffuse large B-cell
lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In
addition, patients with advanced age or significant comorbidities, who are consequently not
candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective
studies investigating new salvage regimens are essential.
The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage
regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile
for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is
a potent killer of ABC DLBCL cell lines in vitro and in xenografts.
It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and
well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II
trial, to investigate the safety and efficacy of the combination of ibrutinib with rituximab,
gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as salvage
therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to stem cell
transplant.
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