Actively Recruiting
Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Led by Zhengzhou University · Updated on 2024-10-15
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 10^6 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form
- Aged between 18 and 70 years inclusive
- Diagnosed with previously untreated CD19-positive large B-cell lymphoma
- Anticipated survival of at least 12 weeks
- Adequate bone marrow reserve before apheresis
- Appropriate organ function
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1
- No central nervous system lymphoma
- Negative blood or urine pregnancy test in women of childbearing age
You will not qualify if you...
- Allergy history to any components of the cell product
- History of stem cell transplantation
- History of organ transplantation
- Presence of active infections
- Current or history of central nervous system disorders
- Previous treatment with other modified T-cell therapy
- Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies
- Malignancies other than those allowed in this trial
- History of prior systemic immune checkpoint therapy
- History of short-acting cell growth factors or hematopoietic agonists/stimulants
- History of a live vaccine within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with monitoring as per protocol
Participants receive Axicabtagene Ciloleucel at 2.0×10^6/Kg as consolidation therapy after first-line treatment for high-risk large B-cell lymphoma.
1 treatment visit and several monitoring visits during treatment period
Duration - Up to 12 months
Participants are monitored for disease progression and survival for up to one year after enrollment.
Regular visits during follow-up period as scheduled
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Z
Zhang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here