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Relapsed/Refractory Diffuse Large B Cell LymphomaZUMA-9NCT03153462

Axicabtagene Ciloleucel Expanded Access Study

A study testing Axicabtagene Ciloleucel in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma and Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, run by Kite, A Gilead Company at 15 sites in United States.

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Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axicabtagene Ciloleucel
Type of treatment
Injection or infusion
How many people
Not given
Where
15 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed large B-cell lymphoma, including the following types:
  • DLBCL, not otherwise specified
  • Primary mediastinal large B-cell lymphoma
  • High-grade B-cell lymphoma
  • DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)
  • Relapsed or refractory disease, defined as one or more of the following:
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  • No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded OR
  • No response or relapse to second or greater lines of therapy OR
  • Relapsed after ASCT
  • Subjects must have received adequate prior therapy including at a minimum:
  • anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
  • an anthracycline containing chemotherapy regimen;
  • No evidence, suspicion, and/or history of central nervous system (CNS) involvement of lymphoma
  • Age 18 or older
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count ANC ≥1000/μL
  • Platelet count ≥75,000/μL
  • Absolute lymphocyte count ≥100/μL
  • Adequate renal, hepatic, pulmonary and cardiac function defined as:
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
  • Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 upper limit of normal (ULN)
  • Total bilirubin ≤1.5 mg/dL, except in subjects with Gilbert's syndrome.
  • Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion within 180 days provide the subject did not receive an anthracycline based treatment or experience a cardiac event or change in performance status
  • No clinically significant pleural effusion
  • Baseline oxygen saturation >92% on room air
  • Cohort 2 inclusion criteria: Subjects whose commercial manufacture of axicabtagene ciloleucel did not meet commercial release specification(s)

Who cannot join

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
  • History of allogeneic stem cell transplantation (SCT)
  • Prior CD19 targeted therapy
  • Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  • Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Pharma Medical Monitor
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  • History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines
  • History or presence of primary CNS lymphoma and/or CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  • Cohort 2 exclusion criteria: Any medical condition that, deemed by the investigator, may interfere with assessment of safety or efficacy of study treatment

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Washington Medical Center

    Seattle, Washington, 98109

  • Stanford Cancer Institute

    Stanford, California, 94305

  • H. Lee Moffitt Cancer and Research Institute

    Tampa, Florida, 33612

  • The University of Kansas Hospital Investigational Drug Services

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Multicenter, Open-label, Expanded Access Study of Axicabtagene Ciloleucel for the Treatment of Subjects With Relapsed/Refractory Large B-cell Lymphoma.

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

Being tested
Axicabtagene Ciloleucel
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axicabtagene CiloleucelBiological

    Also called Yescarta®

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153462
Sponsor's protocol ID
KTE-C19-109
Other IDs
2015-005007-86, 2015
Acronym
ZUMA-9
Status last verified
Nov 2023
First submitted
11 May 2017
Last updated
8 Nov 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Axicabtagene Ciloleucel in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma and Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, run by Kite, A Gilead Company at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03153462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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