A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF); 2. Age above 18 years old (including 18 years old)，regardless of gender; 3. Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that could be measured accurately at baseline according to RECIST1.1 criteria; 4. IPI score 0-2; 5. ECOG score of 0-2； 6. No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology test, and no platelet transfusion or blood transfusion； 7. Estimated survival greater than 3 months； 8. Adequate organ function； 9. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study; 10. 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