Using Trilaciclib with Chemotherapy for Patients with Diffuse Large B-Cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a phase II, single-arm, multi-center study aimed at evaluating the efficacy and safety of Trilaciclib in patients with diffuse large B-cell lymphoma (DLBCL) who are receiving R-CHOP chemotherapy. The study will assess the myeloprotection efficacy of Trilaciclib, focusing on its ability to reduce chemotherapy-induced myelosuppression, specifically the incidence of Grade ≥ 3 neutropenia. A total of 38 eligible subjects will be treated with Trilaciclib prior to their chemotherapy regimen, and researchers will monitor adverse events throughout the trial. The study will follow strict inclusion criteria to ensure participant safety and compliance with treatment protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Medical Oncology, Sun Yat-Sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.