Using Axicabtagene Ciloleucel to improve outcomes after initial treatment for high-risk Large B-cell Lymphoma
Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
This study is testing if a one-time treatment with Axicabtagene Ciloleucel can help people with high-risk Large B-cell Lymphoma do better after their initial therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhengzhou University Academic / other |
| Drugs / interventions | atezolizumab |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06609304 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Axicabtagene Ciloleucel (axi-cel) as a consolidation therapy following first-line treatment in patients with high-risk Large B-cell Lymphoma (LBCL). Participants will receive a one-time infusion of axi-cel and will be monitored for clinical benefits and safety throughout the treatment process. The study will assess whether this therapy can prolong patient outcomes and identify any associated medical issues during treatment. It is an investigator-initiated, single-arm trial conducted at a single institution.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with untreated CD19-positive large B-cell lymphoma and an anticipated survival of at least 12 weeks.
Not a fit: Patients with a history of central nervous system disorders or previous treatments with modified T-cell therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with high-risk LBCL.
How similar studies have performed: Other studies have shown promising results with similar CAR T-cell therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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;.
Where this trial is running
Zhengzhou, Henan
- The First Affiliated Hospital of Zhengzhou University, Department of Oncology — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhang, PhD
- Email: fcczhangxd@zzu.edu.cn
- Phone: 86-0371-66279567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.