A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

Launched by SUN YAT-SEN UNIVERSITY · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Diffuse Large B-Cell Lymphoma (DLBCL), a type of blood cancer. The researchers are looking at the effects of a drug called Trilaciclib when combined with standard chemotherapy known as R-CHOP. The goal is to see if this combination is effective in treating DLBCL and to ensure it is safe for patients.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of DLBCL that has not been treated before. They should have one measurable tumor lesion and meet certain health criteria, including having a good level of overall health. Participants will receive the treatment and will be closely monitored throughout the study, which includes regular visits and lab tests. It’s important to know that women who can become pregnant will need to take a pregnancy test before starting the trial and agree to use effective contraception during the study. Overall, this trial aims to find better treatment options for patients with DLBCL.

Gender

ALL

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 potential must agree to use highly effective contraceptive methods during the study period and within 3 months after the last dose of study drug.
• Exclusion Criteria:
• • 1. The subject is participating in other interventional clinical studies;
• • 2. The subject has previous or concurrent other malignancies;
• • 3. Lymphoma bone marrow invasion;
• • 4. The presence of symptomatic brain metastases requiring immediate radiotherapy or steroid therapy;
• • 5. Known hypersensitivity to the applied drugs or any excipients；
• • 6. Previous hematopoietic stem cell or bone marrow transplantation；
• • 7. Active infection requiring systemic treatment;
• • 8. Patients with uncontrolled cardiac clinical symptoms or diseases;
• • 9. The subject has severe active infection or unexplained fever \> 38.5 degrees during screening or before the first dose (the subject can be enrolled due to tumor fever as judged by the investigator);
• • 10. Radiotherapy or radiotherapy at any site within 2 weeks before study medication;
• • 11. Any investigational drug within 4 weeks before study medication;
• • 12. Live attenuated vaccine within 4 weeks before study medication or possibly during the study period, influenza vaccine can be administered during the influenza season;
• • 13. Pregnant or lactating women;
• • 14. Any reasons that the investigator believes that it should be excluded from this study.