A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
NCT Number: NCT06569485
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: DLBCL
Interventions: DRUG: Trilaciclib+R-CHOP
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-23
Completion Date: 2027-12-01
Locations: Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, China

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.

Primary Outcome Measures: Occurrence of Grade 3/4 neutropenia, 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, Up to 6 months
Secondary Outcome Measures: ORR, 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, Up to 6 months|2y-PFS, Progression-free survival (PFS per RECIST 1.1) is defined as the time until the first imaging disease progression or death (whichever occurs first), Up to 2 years|2y-OS, Overall survival (OS) is defined as the time until the subject's death due to any reason, Up to 2 years|Neutrophil-related myeloprotection efficacy, Occurrence of febrile neutropenia adverse events(AEs), Up to 6 months|Neutrophil-related myeloprotection efficacy, Occurrence of Granulocyte colony-stimulating factor(G-CSF) administration, Up to 6 months|RBC related myeloprotection efficacy, Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, Up to 6 months|RBC related myeloprotection efficacy, Occurrence of erythropoiesis-stimulating agent(ESA) administration, Up to 6 months|Platelet related myeloprotection efficacy, Occurrence of Grade 3/4 decrease of platelets, Up to 6 months|Platelet related myeloprotection efficacy, Occurrence and number of platelet transfusions, Up to 6 months|Platelet related myeloprotection efficacy, Occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration, Up to 6 months|Myeloprotection efficacy, Hospitalization due to chemotherapy-induced myelosuppression, Up to 6 months|Chemotherapy dosing, Chemotherapy dose reductions and delays due to chemotherapy-induced myelosuppression, Up to 6 months|Incidence of Treatment-Emergent Adverse Events, 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., Up to 6 months
Other Outcome Measures: Exploratory analysis of potential biomarkers related with the outcome, The change from baseline in immune cell levels in peripheral blood after treatment includes, but is not limited to:

T cells (CD3, CD4, and CD8) B cells (CD19) Effector T cells (IFN-γ-producing CD4+ T cells, IL-2-producing CD4+ T cells, IL-17-producing CD4+ T cells, IFN-γ-producing CD8+ T cells, IL-2-producing CD8+ T cells) T cell activation markers (HLA-DR+ CD4+ T cells, HLA-DR+ CD8+ T cells) Regulatory T cells (Treg cells) (FoxP3, CD25, and CD127) Proportion of cells in the S phase, Up to 6 months|Exploratory analysis of potential biomarkers related with the outcome, Tumor Biomarkers: Including but not limited to the relationship between the CDK4/6-Cyclin D-RB pathway and antitumor efficacy, the relationship between PD-L1, Ki67, and antitumor efficacy, Up to 6 months