A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

ConditionDLBCL

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

Trilaciclib+R-CHOP
Drug
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.

Treatment groups

38 Participants

are divided into 1 treatment group

Group A: Intervention/TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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