A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
- Conditions
- DLBCL
- Interventions
- Drug: Trilaciclib+R-CHOP
- Registration Number
- NCT06569485
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
This is a prospective, single-arm, multi-center, phase II clinical study to investigate the myeloprotection efficacy, antitumor efficacy, and safety of Trilaciclib in DLBCL patients treated with R-CHOP (rituximab, cyclophosphamide, doxorubicin or Epirubicin, vincristine, and prednisone). 38 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of Trilaciclib before chemotherapy R-CHOP, after signing informed consent. The incidence of Grade ≥ 3 neutropenia was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression (CIM). Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38
- Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
- Age above 18 years old (including 18 years old)，regardless of gender;
- Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that could be measured accurately at baseline according to RECIST1.1 criteria;
- IPI score 0-2;
- ECOG score of 0-2；
- No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology test, and no platelet transfusion or blood transfusion；
- Estimated survival greater than 3 months；
- Adequate organ function；
- Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
- 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.
- The subject is participating in other interventional clinical studies;
- The subject has previous or concurrent other malignancies;
- Lymphoma bone marrow invasion;
- The presence of symptomatic brain metastases requiring immediate radiotherapy or steroid therapy;
- Known hypersensitivity to the applied drugs or any excipients；
- Previous hematopoietic stem cell or bone marrow transplantation；
- Active infection requiring systemic treatment;
- Patients with uncontrolled cardiac clinical symptoms or diseases;
- 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);
- Radiotherapy or radiotherapy at any site within 2 weeks before study medication;
- Any investigational drug within 4 weeks before study medication;
- Live attenuated vaccine within 4 weeks before study medication or possibly during the study period, influenza vaccine can be administered during the influenza season;
- Pregnant or lactating women;
- Any reasons that the investigator believes that it should be excluded from this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention/Treatment Trilaciclib+R-CHOP Experimental: Trilaciclib+R-CHOP Patients with DLBCL were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with Rituximab (375 mg/m2，d0), Cyclophosphamide (50 mg/m2，d1), Doxorubicin (50 mg/m2，d1) or Epirubicin（60 mg/m2，d1）, Vincristine (1.4 mg/m2), and Prednisone (100 mg，d1-5). A total of 6 cycles of treatment were performed every 21 days as a cycle.
- Primary Outcome Measures
Name Time Method Occurrence of Grade 3/4 neutropenia Up to 6 months Proportion of subjects with at least one absolute neutrophil count (ANC) \< 1.0 × 10\^9/L enrolled and treated with at least one dose of trilaciclib
- Secondary Outcome Measures
Name Time Method Platelet related myeloprotection efficacy Up to 6 months Occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration
ORR Up to 6 months Objective Response Rate (ORR) is defined as the percentage of participants achieving complete response (CR) and partial response (PR) for tumor volume reduction and maintaining the minimum duration requirement based on RECIST v1.1
Myeloprotection efficacy Up to 6 months Hospitalization due to chemotherapy-induced myelosuppression
2y-PFS Up to 2 years Progression-free survival (PFS per RECIST 1.1) is defined as the time until the first imaging disease progression or death (whichever occurs first)
Neutrophil-related myeloprotection efficacy Up to 6 months Occurrence of Granulocyte colony-stimulating factor(G-CSF) administration
2y-OS Up to 2 years Overall survival (OS) is defined as the time until the subject's death due to any reason
Incidence of Treatment-Emergent Adverse Events Up to 6 months To assess the effects of trilaciclib administered prior to chemotherapy on the occurrence and severity of adverse events by CTCAE 5.0, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest.
RBC related myeloprotection efficacy Up to 6 months Occurrence of erythropoiesis-stimulating agent(ESA) administration
Chemotherapy dosing Up to 6 months Chemotherapy dose reductions and delays due to chemotherapy-induced myelosuppression
Trial Locations
- Locations (1)
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China