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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are: * Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving axi-cel treatment? In this investigator-initiated, single-arm clinical trial, participants will: * Receive atezolizumab treatment at 2.0×10\^6 cells/Kg as a one-time therapy. * Visit the clinic as instructed for checkups and tests.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Understand and voluntarily sign the informed consent form;

• 18-70 years of age (inclusive);

• Previously untreated CD19-positive large B-cell lymphoma;

• Anticipated survival ≥12 weeks;

• Adequate bone marrow reserve prior to apheresis

• Appropriate organ function:

• Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;

⁃ 9\. Negative blood/urine pregnancy test in women of childbearing age.

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
RECRUITING
Zhengzhou
Contact Information
Primary
Zhang, PhD
fcczhangxd@zzu.edu.cn
86-0371-66279567
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 20
Treatments
Experimental: axi-cel treatment
Related Therapeutic Areas
Sponsors
Leads: Zhengzhou University

This content was sourced from clinicaltrials.gov