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Phase 2
Age: 18Years +
All Genders
ID06569485

Phase 2 Study of Trilaciclib with R-CHOP Chemotherapy for Patients with Diffuse Large B-Cell Lymphoma

Led by Sun Yat-sen University · Updated on 2024-08-26

38

Participants Needed

1

Research Sites

152 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Trilaciclib combined with chemotherapy in patients with diffuse large B-cell lymphoma DLBCL. This phase II, single-arm, multi-center study aims to assess whether Trilaciclib can protect bone marrow from damage caused by chemotherapy and improve treatment outcomes. The primary focus is on reducing severe neutropenia, a condition of low white blood cells that can result from chemotherapy. Participants receive Trilaciclib at a dose of 240 mgm2 on day 1, given within four hours before each chemotherapy session. The chemotherapy regimen used is R-CHOP, which includes rituximab, cyclophosphamide, doxorubicin or epirubicin, vincristine, and prednisone. Patients undergo six treatment cycles, each lasting 21 days, with Trilaciclib administered prior to each cycle. During the study, patients will undergo regular monitoring for side effects and treatment responses. Researchers will track the occurrence of severe neutropenia and other blood-related protective effects over six months. Additional assessments include overall response rate and survival outcomes up to two years. Safety will be closely observed using standard guidelines. The total participation duration covers the treatment and follow-up periods to evaluate both short- and long-term effects.

CONDITIONS

Brief Title

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

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