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

Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP.

This study is testing if adding Trilaciclib to chemotherapy can help people with diffuse large B-cell lymphoma avoid serious side effects like low white blood cell counts.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: rituximab, chemotherapy, cyclophosphamide, doxorubicin, prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06569485 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with treatment-naive, histologically confirmed DLBCL and an IPI score of 0-2.

Not a fit: Patients with prior chemotherapy treatments or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the side effects of chemotherapy in DLBCL patients, improving their overall treatment experience and outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing chemotherapy-induced myelosuppression, suggesting potential for success in this trial.

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.

Where this trial is running

Guangzhou, Guangdong

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

Conditions DLBCL