Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569485
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None