COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Axicabtagene Ciloleucel Expanded Access Study (ZUMA-9)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03153462
Expanded Access Status : Available
First Posted : May 15, 2017
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

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

Condition or disease Intervention/treatment
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 Biological: Axicabtagene Ciloleucel

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: A Multicenter, Open-label, Expanded Access Study of Axicabtagene Ciloleucel for the Treatment of Subjects With Relapsed/Refractory Large B-cell Lymphoma.

Intervention Details:
  • 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Histologically confirmed large B-cell lymphoma, including the following types:

    1. DLBCL, not otherwise specified
    2. Primary mediastinal large B-cell lymphoma
    3. High-grade B-cell lymphoma
    4. DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)
  2. Relapsed or refractory disease, defined as one or more of the following:

    1. No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded OR
    2. No response or relapse to second or greater lines of therapy OR
    3. Relapsed after ASCT
  3. Subjects must have received adequate prior therapy including at a minimum:

    1. anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
    2. an anthracycline containing chemotherapy regimen;
  4. No evidence, suspicion, and/or history of central nervous system (CNS) involvement of lymphoma
  5. Age 18 or older
  6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  7. Absolute neutrophil count ANC ≥1000/μL
  8. Platelet count ≥75,000/μL
  9. Absolute lymphocyte count ≥100/μL
  10. Adequate renal, hepatic, pulmonary and cardiac function defined as:

    1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
    2. Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 upper limit of normal (ULN)
    3. Total bilirubin ≤1.5 mg/dL, except in subjects with Gilbert's syndrome.
    4. 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
    5. No clinically significant pleural effusion
    6. Baseline oxygen saturation >92% on room air
  11. Cohort 2 inclusion criteria: Subjects whose commercial manufacture of axicabtagene ciloleucel did not meet commercial release specification(s)

Exclusion Criteria:

  1. 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
  2. History of allogeneic stem cell transplantation (SCT)
  3. Prior CD19 targeted therapy
  4. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
  5. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  6. 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
  7. 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
  8. 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
  9. Cohort 2 exclusion criteria: Any medical condition that, deemed by the investigator, may interfere with assessment of safety or efficacy of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03153462

Layout table for location contacts
Contact: Medical Information 1-844-454-5483(1-844-454-KITE)

Layout table for location information
United States, California
City of Hope Available
Duarte, California, United States, 91010
Contact: Elizabeth Budde, MD   
Stanford Cancer Institute Available
Stanford, California, United States, 94305
Contact: Julianna Craig   
United States, Florida
University of Miami Hospital and Clinics Available
Miami, Florida, United States, 33136
Contact: Lazaros Lekakis   
H. Lee Moffitt Cancer and Research Institute Available
Tampa, Florida, United States, 33612
Contact: Matthew Scott   
United States, Illinois
University of Chicago Medical Center Available
Chicago, Illinois, United States, 60637
Contact: Linda Schroeder   
Principal Investigator: Peter Reidell, MD         
United States, Kansas
The University of Kansas Hospital Investigational Drug Services Available
Westwood, Kansas, United States, 66205
Contact: Renee Sol   
United States, Massachusetts
Dana-Farber Cancer Institute Available
Boston, Massachusetts, United States, 02215
Contact: Michael Rocchio   
United States, Minnesota
Mayo Clinic Available
Rochester, Minnesota, United States, 55905
Contact: Kristin Arends   
United States, Nebraska
University of Nebraska Medical Center Available
Omaha, Nebraska, United States, 68198-7680
Contact: Susan Blumel    402-559-9183   
United States, New York
Roswell Park Cancer Institute Available
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center Available
New York, New York, United States, 10065
Contact: Miguel-Angel Perales, MD       peralesm@MSKCC.ORG   
United States, Ohio
Cleveland Clinic Available
Cleveland, Ohio, United States, 44195
Contact: Brian Hill   
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Available
Columbus, Ohio, United States, 43210
Contact: Nicole Szuminski   
United States, Texas
The University of Texas MD Anderson Cancer Center Available
Houston, Texas, United States, 77030-4000
Contact: Sherry Adkins   
Contact: Liliana Vallejo   
United States, Washington
University of Washington Medical Center Available
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Kite, A Gilead Company
Layout table for investigator information
Study Director: Kite Study Director Kite, A Gilead Company
Layout table for additonal information
Responsible Party: Kite, A Gilead Company Identifier: NCT03153462    
Other Study ID Numbers: KTE-C19-109
2015-005007-86 ( EudraCT Number )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin