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Trial record 4 of 5 for:    KTE-X19

Study of KTE-X19 for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18)

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: NCT04162756
Expanded Access Status : Available
First Posted : November 14, 2019
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Brief Summary:
The primary objective of this study is to provide access to KTE-X19 for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available.

Condition or disease Intervention/treatment
Relapse/Refractory Mantle Cell Lymphoma Biological: KTE-X19 Drug: Fludarabine Drug: Cyclophosphamide

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies

Intervention Details:
  • Biological: KTE-X19
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
  • Drug: Fludarabine
    Administered per package insert
  • Drug: Cyclophosphamide
    Administered per package insert

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.

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

Key Inclusion Criteria:

  • Pathologically confirmed mantel cell lymphoma (MCL), with documentation of either overexpression of cyclin D1 or presence of t(11;14)
  • Received at least one prior regimen for MCL. Prior therapy must have included:

    • Anthracycline or bendamustine-containing chemotherapy, and
    • Anti-CD20 monoclonal antibody therapy, and
    • Treatment with Bruton's tyrosine kinase inhibitor (BTKi): ibrutinib, acalabrutinib, or a BTKi in a clinical trial for r/r MCL.
  • Relapsed or refractory disease, defined by the following:

    • Disease progression after last regimen, or
    • Failure to achieve a partial response (PR) or complete response (CR) to the last regimen
  • Magnetic resonance imaging (MRI) of the brain showing no evidence of central nervous system (CNS) lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Absolute neutrophil count (ANC) ≥ 1,000/uL
  • Platelet count ≥ 75,000/uL
  • Absolute lymphocyte count ≥ 100/uL
  • Adequate renal, hepatic, pulmonary, and cardiac function defined as:

    • Creatinine clearance (as estimated by Cockcroft Gault formula) ≥ 60 cc/min
    • Serum alanine aminotransferase/aspartate aminotransferase (ALT)/AST) ≤ 2.5 x upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome
    • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
    • No clinically significant pleural effusion
    • Baseline oxygen saturation > 92% on room air

Key Exclusion Criteria:

  • Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.
  • History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or hepatitis C infection.
  • Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or with a history of CNS lymphoma, CSF malignant cells, or brain metastases
  • History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement

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

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): NCT04162756

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Contact: Medical Information 844-454-5483(1-844-454-KITE)

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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Available
Hackensack, New Jersey, United States, 07601
United States, Texas
The University of TX MD Anderson Cancer Center Available
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kite, A Gilead Company
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Study Director: Kite Study Director Kite, A Gilead Company

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Responsible Party: Kite, A Gilead Company Identifier: NCT04162756    
Other Study ID Numbers: KT-US-472-0118
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists