Virginia Commonwealth University
This study is a single-arm, open label, non-randomized, phase 2 trial of zanubrutinib in patients with diffuse large B-cell lymphoma (DLBCL) who have an MYD88 L265P mutation, a CD79B mutation, a NOTCH1 truncation, or who are CD5+ by immunohistochemistry (IHC).
The purpose of this study is to compare effects of adding zanubrutinib to the usual chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL) who have an MYD88 L265P mutation, a CD79B mutation, a NOTCH1 truncation, or who are CD5+ by IHC. In those patients with mutations or IHC result, we propose treating with zanubrutinib plus rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone (R-CHOP). Patients will be monitored with standard imaging; minimal residual disease (MRD) testing will be optional. The primary outcome…
Inclusion Criteria: * Patients must have a documented pathologic diagnosis of DLBCL at any stage. * Must have documented MYD88 L265P, CD79B, or NOTCH1 truncation mutation or be CD5+ by IHC. * Age ≥18 years on the day of signing the informed consent form. * Patients must have measurable disease on Positron Emission Tomography-Computed Tomography scan (CT/PET) imaging. * Patient must have received no more than one cycle of R-CHOP prior to enrollment. Length of time between first R-CHOP treatment and planned 2nd R-CHOP treatment should vary by no more than 21 days ± 3 days. * Eastern Cooperative…
Investigational Agent Administration. Zanubrutinib will be first administered on Cycle 2 Day 1 of rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone (R-CHOP). It is up to the discretion of the treating physician how many cycles of R-CHOP the treatment would require, but it is not to exceed 6 cycles of R-CHOP and 5 cycles of zanubrutinib. The number of cycles of R-CHOP should be per standard of care, with the number of zanubrutinib cycles being 1 less than the number of total R-CHOP cycles.
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