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Axicabtagene Ciloleucel Expanded Access Study (ZUMA-9)

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ClinicalTrials.gov Identifier: NCT03153462
Expanded Access Status : Approved for marketing
First Posted : May 15, 2017
Last Update Posted : March 23, 2021
Sponsor:
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

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
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.
    Other Name: Yescarta®

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03153462


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Stanford Cancer Institute
Stanford, California, United States, 94305
United States, Florida
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Kansas
The University of Kansas Hospital Investigational Drug Services
Westwood, Kansas, United States, 66205
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Kite Study Director Kite, A Gilead Company
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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov 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: March 23, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin