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

NCT07254754 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • DIFFUSE LARGE B-CELL LYMPHOMA

Interventions

DRUG

Axicabtagene 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.

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • Evidenze Health España (CRO)

    collaborator UNKNOWN

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Mariana Bastos-Oreiro · Hospital General Universitario Gregorio Marañón

  • Alejandro Martín García-Sancho · Hospital Universitario Salamanca

  • Armando López-Guillermo · Hospital Clinic of Barcelona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2027-01-31
Completion
2031-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254754 on ClinicalTrials.gov