Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP.
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP.
• Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
• Age above 18 years old (including 18 years old)，regardless of gender;
• Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that could be measured accurately at baseline according to RECIST1.1 criteria;
• IPI score 0-2;
• ECOG score of 0-2；
• No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology test, and no platelet transfusion or blood transfusion；
• Estimated survival greater than 3 months；
• Adequate organ function；
• Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
⁃ Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 3 months after the last dose of study drug.