Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP.

Sun Yat-sen University1 site in 1 country38 target enrollmentMay 23, 2024

ConditionsDLBCL

InterventionsTrilaciclib+R-CHOP

Overview

Phase: Phase 2
Intervention: Trilaciclib+R-CHOP
Conditions: DLBCL
Sponsor: Sun Yat-sen University
Enrollment: 38
Locations: 1
Primary Endpoint: Occurrence of Grade 3/4 neutropenia
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 23, 2024

End Date

December 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Li Zhiming

Chief Physician

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Arms & Interventions

Intervention/Treatment

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.

Intervention: Trilaciclib+R-CHOP