Examining the role of inflammation in blood cell deficiencies after CAR-T therapy
Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy: Potential of Therapies Directed to Repair the Bone Marrow Microenvironment
This study is trying to see how inflammation affects blood cell problems in patients with diffuse large B-cell lymphoma after they receive CAR-T therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, Immunotherapy |
| Locations | 1 site (Salamanca) |
| Trial ID | NCT06439173 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with diffuse large B-cell lymphoma who have undergone CAR-T cell therapy. It aims to analyze the characteristics of the hematopoietic niche and the inflammatory status in patients experiencing prolonged cytopenias compared to those without. The study will involve a series of 40 patients and will utilize techniques such as immunohistochemistry, flow cytometry, and genomic studies to gather data. The goal is to better understand the complications arising from CAR-T therapy and explore potential therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with diffuse large B-cell lymphoma who are undergoing CAR-T cell therapy.
Not a fit: Patients under 18 years old or those who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment options for patients suffering from cytopenias after CAR-T therapy.
How similar studies have performed: While the approach of analyzing the hematopoietic niche and inflammation is gaining interest, this specific study appears to be novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy * Over 18 years old * Sign the informed consent Exclusion Criteria: * Under 18 years old * Do not sign the informed consent
Where this trial is running
Salamanca
- Complejo Asistencial Universitario de Salamanca — Salamanca, Spain (Recruiting)
Study contacts
- Study coordinator: Fermín Sánchez-Guijo Martín, PhD MD
- Email: ferminsg@usal.es
- Phone: +34 923 291384
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.