IRiC : A Phase II Study of Ibrutinib, Rituximab and mini-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in very elderly patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Trial Identifiers

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• ACTRN12615000551594
• ALLG NHL29, IRIC STUDY

Scientific Title

A Phase II Study of Ibrutinib, Rituximab and mini-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in very elderly patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Cooperative Group

Australasian Leukaemia and Lymphoma Group (ALLG)

Summary

The study will evaluate the deliverability and efficacy of Ibrutinib-R-mini-CHOP chemotherapy in elderly patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Who is it for? You may be eligible to join this study if you are aged 75 years or above and have been newly diagnosed with DLBCL for which you have received no prior treatment (excluding prednisone). Study details All participants in this study will be treated with a chemotherapy regime known as Ibrutinib-R-mini-CHOP. This will include treatment with the drugs prednisone (orally), ibrutinib (orally), rituximab intravenously ((IV) - i.e. administered directly into the vein), cyclophosphamide IV, doxorubicin IV, vincristine IV and Pegfilgrastim G-CSF (subcutaneous injection). Treatment duration will be for up to 8 x 28 day cycles as tolerated. All participants will be regularly assessed for a minimum of 2 years in order to evaluate the safety, toxicity and effectiveness of treatment.