Actively Recruiting
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
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Age between 18 and 70 years inclusive
- 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...
- History of allergy 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 indicated for this trial
- History of any prior systemic immune checkpoint therapy
- History of short-acting cell growth factors or hematopoietic agonists/stimulants
- History of a live vaccine within 3 months prior to screening
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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