drugset / Trial / NCT02670317

Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.

NCT02670317 ↗

Phase 2 Terminated 1 enrolled Fondazione Italiana Linfomi - ETS
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-09
Primary completion
2017-02
Completion
2017-02

Outcome

Outcome not reported

Stopped: “GA101-CHOP not advantage from rituximab-CHOP”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — —
Subject Doxorubicin Other / unclassified — —
Subject Ibrutinib Small molecule — —
Subject Obinutuzumab Monoclonal antibody — —
Subject Prednisone Other / unclassified — —
Subject Vincristine Small molecule — —

Indications