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

NCT06569485 | Recruiting Phase 2

• 1 other identifier: B2024-253-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 6 months

Secondary Outcomes (13)

• ORR

  Up to 6 months

• 2y-PFS

  Up to 2 years

• 2y-OS

  Up to 2 years

• Neutrophil-related myeloprotection efficacy

  Up to 6 months

• Neutrophil-related myeloprotection efficacy

  Up to 6 months

Other Outcomes (2)

• Exploratory analysis of potential biomarkers related with the outcome

  Up to 6 months

• Exploratory analysis of potential biomarkers related with the outcome

  Up to 6 months

Study Arms (1)

Intervention/Treatment

EXPERIMENTAL

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.

Drug: Trilaciclib+R-CHOP

Interventions

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.

Also known as: G1T28

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Any investigational drug within 4 weeks before study medication;
• Live attenuated vaccine within 4 weeks before study medication or possibly during the study period, influenza vaccine can be administered during the influenza season;
• Pregnant or lactating women;
• Any reasons that the investigator believes that it should be excluded from this study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Medical Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 26, 2024
• Study Start: May 23, 2024
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

CN (1)