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Trial Title:
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
NCT ID:
NCT06609304
Condition:
Lymphoma, B-Cell
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Axicabtagene ciloleucel
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Axicabtagene Ciloleucel
Description:
Axicabtagene Ciloleucel at 2.0×10^6/Kg
Arm group label:
axi-cel treatment
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form;
2. 18-70 years of age (inclusive);
3. Previously untreated CD19-positive large B-cell lymphoma;
4. Anticipated survival ≥12 weeks;
5. Adequate bone marrow reserve prior to apheresis
6. Appropriate organ function:
7. 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.
Exclusion Criteria:
1. History of allergy to any of the components of the cell product;
2. History of stem cell transplantation;
3. History of organ transplantation;
4. Presence of active infections;
5. Current or history of central nervous system disorders;
6. Previous treatment with other modified T-cell therapy;
7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
8. Malignancies other than those indicated for this trial;
9. History of any prior systemic immune checkpoint therapy;
10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
11. History of a live vaccine within 3 months prior to screening;.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Xudong Zhang, PhD
Phone:
86-0371-66279567
Email:
fcczhangxd@zzu.edu.cn
Start date:
September 30, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Zhengzhou University
Agency class:
Other
Source:
Zhengzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609304
