Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.

Official Title

A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting

Details

Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Keywords

Relapsed or Refractory Large B-cell Lymphoma, Lymphoma, B-Cell Lymphoma, Dexamethasone, Cyclophosphamide, Fludarabine, Axicabtagene ciloleucel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below:
    • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
    • High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement.
    • DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL.
    • Primary mediastinal (thymic) LBCL.
    • Primary cutaneous DLBCL, leg type.
    • Transformation of follicular lymphoma to DLBCL will also be included.
  • Relapsed or refractory disease after 1 or more lines of therapy.
  • Individuals must have received adequate prior therapy including:
  • At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements.

You CAN'T join if...

  • History of autologous or allogeneic stem cell transplant.
  • Prior cluster of differentiation (CD)19 targeted therapy.
  • Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
  • Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease.
  • In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCLA
    Los Angeles California 90025 United States
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT05459571
Phase
Phase 2 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 35 study participants
Last Updated