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Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2025-12-01

Study results available
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Summary

The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Conditions

  • Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

Administered intravenously

DRUG

Platinum-containing Salvage Chemotherapy

Platinum-containing salvage chemotherapy (Rituximab-ifosfamide, carboplatin, etoposide (R-ICE), Rituximab-dexamethasone, cytarabine, cisplatin,oxaliplatin (R-DHAP), Rituximab-etoposide, methylprednisolone, cisplatin, cytarabine (R-ESHAP), or Rituximab-gemcitabine, dexamethasone, cisplatin/carboplatin (R-GDP) as selected by treating investigator).

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

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
2018-01-25
Primary Completion
2021-03-18
Completion
2024-11-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT03391466 on ClinicalTrials.gov