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Phase 4
Age: 18Years - 70Years
All Genders
ID06609304

Study of Axicabtagene Ciloleucel Treatment After First-line Therapy for High-risk Large B-cell Lymphoma in Adults Aged 18 to 70

Led by Zhengzhou University · Updated on 2024-10-15

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Axicabtagene Ciloleucel axi-cel as a consolidation treatment after first-line therapy for patients with high-risk large B-cell lymphoma LBCL. This Phase 4 clinical trial aims to understand whether axi-cel can provide prolonged clinical benefits and assess the safety of this treatment in this patient group. The study is investigator-initiated and focuses on patients who have not received prior treatment for CD19-positive large B-cell lymphoma. Participants will receive a single dose of axi-cel at 2.0 x 106 cells per kilogram as the investigational treatment. The trial is single-arm, meaning all participants receive the same therapy without a comparison group. Treatment will be followed by regular clinic visits for monitoring and evaluation according to the study schedule. During the study, participants will undergo checkups and tests to monitor their health and response to treatment. Researchers will specifically measure progression-free survival over one year from enrollment, tracking any disease progression or death from any cause. The study includes careful safety monitoring and will last through the planned follow-up period ending in August 2027.

CONDITIONS

Brief Title

Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Research Team

Z

Zhang, PhD

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