Lymphoma, B-Cell Clinical Trial
Official title:
Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients.
This is a prospective, multicenter, single arm, phase II trial in young patients (18-60
years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma
(DLBCL).
Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with
ibrutinib.
This is a prospective, multicenter, single arm, phase II trial in young patients (18-60
years) with poor-prognosis (age-adjusted International Prognostic Index, aaIPI, 2 or 3)
newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL).
Patient will receive 6 courses of G-CHOP21 (Obimutizumab- cyclophosphamide,
hydroxydaunomycin, Oncovin, and prednisone) followed by 2 doses of Obinutuzumab supplemented
with Ibrutinib. Duration of treatment will be 5 months plus 4-5 weeks for response
evaluation.
During the study, disease status will be evaluated after the 4th cycle by computed
tomography (CT) scan, and after end of treatment by imaging test (18FDG-PET [positron
emission tomography] and CT scan).
Patients will be recruited over 2 years and followed for a minimum of 2 years after the end
of the treatment phase.
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