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Trial Title:
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients
NCT ID:
NCT06569485
Condition:
DLBCL
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trilaciclib+R-CHOP
Description:
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.
Arm group label:
Intervention/Treatment
Other name:
G1T28
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Having sufficient understanding of this study and being willing to sign the informed
consent form (ICF);
2. Age above 18 years old (including 18 years old)，regardless of gender;
3. Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that
could be measured accurately at baseline according to RECIST1.1 criteria;
4. IPI score 0-2;
5. ECOG score of 0-2；
6. No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology
test, and no platelet transfusion or blood transfusion；
7. Estimated survival greater than 3 months；
8. Adequate organ function；
9. Being willing and able to comply with the visits, treatment plan, laboratory
examinations and other study procedures scheduled in the study;
10. 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:
1. The subject is participating in other interventional clinical studies;
2. The subject has previous or concurrent other malignancies;
3. Lymphoma bone marrow invasion;
4. The presence of symptomatic brain metastases requiring immediate radiotherapy or
steroid therapy;
5. Known hypersensitivity to the applied drugs or any excipients；
6. Previous hematopoietic stem cell or bone marrow transplantation；
7. Active infection requiring systemic treatment;
8. Patients with uncontrolled cardiac clinical symptoms or diseases;
9. 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);
10. Radiotherapy or radiotherapy at any site within 2 weeks before study medication;
11. Any investigational drug within 4 weeks before study medication;
12. Live attenuated vaccine within 4 weeks before study medication or possibly during
the study period, influenza vaccine can be administered during the influenza season;
13. Pregnant or lactating women;
14. Any reasons that the investigator believes that it should be excluded from this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li, MD
Phone:
+86-13719189172
Email:
lizhm@sysucc.org.cn
Start date:
May 23, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06569485
