DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

Exclusion Criteria

• •Cohort 2, 3:
• •a. Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within 14 days prior to first dose. Chemotherapy and small-molecule targeted therapy were not terminated within 5 half-lives before the first dose; macromolecule drug therapy (such as antibody therapy) was not terminated within 28 days before the first dose.
• •All patients should not be included in this study if they have any of the following conditions:
• •1. Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
• •2. Prior use of BTK inhibitors.
• •3. Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
• •4. 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.
• •5. Major surgery within 4 weeks or anticipated surgery after the start of this study. Or insufficiently recovered from any toxicity and/or complications of previous intervention.
• •6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
• •7. Active infectious diseases.
• •8. Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug.
• •9. The patient has been diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.
• •10. Patients with hypersensitivity to DZD8586 drug excipients or other chemical analogues.
• •11. Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.
• •12. Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent
• •13. Women who are pregnant or breastfeeding.