Status:
RECRUITING
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Lead Sponsor:
Zhengzhou University
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of allergy to any of the 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 haematopoietic agonists/stimulants ;
- History of a live vaccine within 3 months prior to screening;.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06609304
Start Date
September 30 2024
End Date
August 31 2027
Last Update
October 15 2024
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, China, 450052