A Phase 2 interventional study of Trilaciclib+R-CHOP in DLBCL, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Prevention
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.
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.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's planned enrollment of 38 is below the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
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.
Drug: Trilaciclib+R-CHOP
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.
Also known as: G1T28
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
Time frame: Up to 6 months
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
Time frame: 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)
Time frame: Up to 2 years
2y-OS
Overall survival (OS) is defined as the time until the subject's death due to any reason
Time frame: Up to 2 years
Neutrophil-related myeloprotection efficacy
Occurrence of febrile neutropenia adverse events(AEs)
Time frame: Up to 6 months
Neutrophil-related myeloprotection efficacy
Occurrence of Granulocyte colony-stimulating factor(G-CSF) administration
Time frame: 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
Time frame: Up to 6 months
RBC related myeloprotection efficacy
Occurrence of erythropoiesis-stimulating agent(ESA) administration
Time frame: Up to 6 months
Platelet related myeloprotection efficacy
Occurrence of Grade 3/4 decrease of platelets
Time frame: Up to 6 months
Platelet related myeloprotection efficacy
Occurrence and number of platelet transfusions
Time frame: Up to 6 months
Platelet related myeloprotection efficacy
Occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration
Time frame: Up to 6 months
Myeloprotection efficacy
Hospitalization due to chemotherapy-induced myelosuppression
Time frame: Up to 6 months
Chemotherapy dosing
Chemotherapy dose reductions and delays due to chemotherapy-induced myelosuppression
Time frame: 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.
Time frame: Up to 6 months
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
Time frame: 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
Time frame: Up to 6 months
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Lymphoma, Large B-Cell, Diffuse→
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