MedTrace Logo

Axicabtagene Ciloleucel Expanded Access Study

NCT03153462 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2023-11-08

No results posted yet for this study

Summary

A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.

Subjects who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Conditions

  • Relapsed/Refractory Diffuse Large B Cell Lymphoma
  • Relapsed/Refractory Primary Mediastinal B Cell Lymphoma
  • Relapsed/Refractory Transformed Follicular Lymphoma
  • Relapsed/Refractory High-Grade B-Cell Lymphoma

Interventions

BIOLOGICAL

Axicabtagene Ciloleucel

Axicabtagene Ciloleucel and A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

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 NCT03153462 on ClinicalTrials.gov