A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
- Conditions
- DLBCL
- Registration Number
- NCT06569485
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria:<br><br> 1. Having sufficient understanding of this study and being willing to sign the informed<br> consent form (ICF);<br><br> 2. Age above 18 years old (including 18 years old),regardless of gender;<br><br> 3. Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that<br> could be measured accurately at baseline according to RECIST1.1 criteria;<br><br> 4. IPI score 0-2;<br><br> 5. ECOG score of 0-2;<br><br> 6. No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology<br> test, and no platelet transfusion or blood transfusion;<br><br> 7. Estimated survival greater than 3 months;<br><br> 8. Adequate organ function;<br><br> 9. Being willing and able to comply with the visits, treatment plan, laboratory<br> examinations and other study procedures scheduled in the study;<br><br> 10. Women of childbearing potential must undergo a serum pregnancy test within 3 days<br> prior to the first dose and the result must be negative. Female patients of<br> childbearing potential and male subjects whose partners are women of childbearing<br> potential must agree to use highly effective contraceptive methods during the study<br> period and within 3 months after the last dose of study drug.<br><br>Exclusion Criteria:<br><br> 1. The subject is participating in other interventional clinical studies;<br><br> 2. The subject has previous or concurrent other malignancies;<br><br> 3. Lymphoma bone marrow invasion;<br><br> 4. The presence of symptomatic brain metastases requiring immediate radiotherapy or<br> steroid therapy;<br><br> 5. Known hypersensitivity to the applied drugs or any excipients;<br><br> 6. Previous hematopoietic stem cell or bone marrow transplantation;<br><br> 7. Active infection requiring systemic treatment;<br><br> 8. Patients with uncontrolled cardiac clinical symptoms or diseases;<br><br> 9. The subject has severe active infection or unexplained fever > 38.5 degrees during<br> screening or before the first dose (the subject can be enrolled due to tumor fever<br> as judged by the investigator);<br><br> 10. Radiotherapy or radiotherapy at any site within 2 weeks before study medication;<br><br> 11. Any investigational drug within 4 weeks before study medication;<br><br> 12. Live attenuated vaccine within 4 weeks before study medication or possibly during<br> the study period, influenza vaccine can be administered during the influenza season;<br><br> 13. Pregnant or lactating women;<br><br> 14. Any reasons that the investigator believes that it should be excluded from this<br> study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of Grade 3/4 neutropenia
- Secondary Outcome Measures
Name Time Method ORR;2y-PFS;2y-OS;Neutrophil-related myeloprotection efficacy;Neutrophil-related myeloprotection efficacy;RBC related myeloprotection efficacy;RBC related myeloprotection efficacy;Platelet related myeloprotection efficacy;Platelet related myeloprotection efficacy;Platelet related myeloprotection efficacy;Myeloprotection efficacy;Chemotherapy dosing;Incidence of Treatment-Emergent Adverse Events