About this trial
This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.
Eligibility criteria
Qualifiers
Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
Disease stage II to IV by Ann Arbor Classification.
Life expectancy ≥ 12 months.
Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).
Disqualifiers
Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
Prior use of BTK inhibitors.
Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
Currently taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, proton pump inhibitor drugs, anti-tumor traditional Chinese medicine or failing to meet the protocol-specified withdrawal time before administration in this study.
Trial design
Treatments tested in this trial
- DZD8586+R-CHOP
- DZD8586+R-GemOx
- DZD8586+BR