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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
38
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.
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOccurrence 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
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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