RecruitingPhase 2NCT07254754

Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma

LATE-R Trial. A Phase II, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Enrollment

45 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of cell therapy called axicabtagene ciloleucel (axi-cel) — a treatment that uses your own immune cells, re-engineered to fight cancer — in patients with diffuse large B-cell lymphoma (DLBCL, an aggressive blood cancer) that came back more than 12 months after their initial complete response. **You may be eligible if...** - You are over 18 years old - You have histologically confirmed relapsed or refractory aggressive B-cell lymphoma (DLBCL or similar) - Your cancer responded completely to initial treatment but has since relapsed - You meet performance and organ function requirements **You may NOT be eligible if...** - Your cancer has spread to the brain or central nervous system - You have significant heart or lung conditions - You have active autoimmune disease requiring treatment - You have had prior CAR-T cell therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAxicabtagene Ciloleucel

Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 106 - 2 × 106 cells/kg), with a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above.

Locations(15)

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Institut Català d'oncologia de L'Hospitalet

L'Hospitalet de Llobregat, Catalonia, Spain

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, Spain

Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07254754

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