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Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

Primary Purpose

Large B-cell Lymphoma, Follicular Lymphoma

Status
Available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Axicabtagene Ciloleucel
Sponsored by
Kite, A Gilead Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Large B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) Deemed medically fit and stable to receive the product per the investigator's evaluation Repeat leukapheresis is not feasible per the investigator's assessment Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release In the investigator's opinion, there is no satisfactory alternative therapy available to the individual Exclusion Criteria: History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system lymphoma

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Beth Israel Deaconess Medical Center
  • Cleveland Clinic
  • Oregon Health & Science University
  • The University of Texas MD Anderson Cancer Center
  • Fred Hutchinson Cancer Center
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
October 18, 2023
Sponsor
Kite, A Gilead Company
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1. Study Identification

Unique Protocol Identification Number
NCT05776160
Brief Title
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Official Title
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kite, A Gilead Company

4. Oversight

5. Study Description

Brief Summary
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large B-cell Lymphoma, Follicular Lymphoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Axicabtagene Ciloleucel
Other Intervention Name(s)
Yescarta®
Intervention Description
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) Deemed medically fit and stable to receive the product per the investigator's evaluation Repeat leukapheresis is not feasible per the investigator's assessment Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release In the investigator's opinion, there is no satisfactory alternative therapy available to the individual Exclusion Criteria: History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system lymphoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
844-454-5483(1-844-454-KITE)
Email
medinfo@kitepharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kite Study Director
Organizational Affiliation
Kite, A Gilead Company
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Available
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Available
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Available
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Available
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Available
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Available
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Available

12. IPD Sharing Statement

Links:
URL
https://www.gileadclinicaltrials.com/study?nctid=NCT05776160
Description
Gilead Clinical Trials Website

Learn more about this trial

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

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