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Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

NCT05371093 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2025-10-15

No results posted yet for this study

Summary

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Conditions

  • Relapsed/Refractory Follicular Lymphoma

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

DRUG

Lenalidomide

Administered orally

DRUG

Rituximab

Administered intravenously

DRUG

Doxorubicin

Administered intravenously

DRUG

Vincristine

Administered intravenously

DRUG

Prednisone

Administered orally

DRUG

Bendamustine

Administered intravenously

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2030-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • United Kingdom

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 NCT05371093 on ClinicalTrials.gov