Relapse/Refractory Mantle Cell LymphomaZUMA-18NCT04162756
Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies
A study testing Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide in people with Relapse/Refractory Mantle Cell Lymphoma, run by Kite, A Gilead Company at 9 sites in United States.
Trial summary
The primary objectives of this study are: Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse/Refractory Mantle Cell Lymphoma
- What is being tested?
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 9 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
- Cohort 1:
- 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, or
- Anti-CD20 monoclonal antibody therapy, or
- Treatment with Bruton's tyrosine kinase inhibitor (BTKi): ibrutinib, acalabrutinib, or a BTKi in a clinical trial for r/r MCL.
Show all 25Show fewer
- 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 or 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 the following:
- 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
- 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.
- At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm.
- Cohort 2:
- Individuals whose commercial manufacture of KTE-X19 did not meet commercial release specification(s)
Who cannot join
- Cohort 1:
- 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.
- History of detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or with a history of CNS lymphoma, CSF malignant cells, or brain metastases
- History 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
- Cohort 2:
- Any medical condition that, as deemed by the treating physician, may interfere with assessment of safety or efficacy of study treatment
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Blood Cancer Institute
Denver, Colorado, 80218
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of TX MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Stanford Cancer Institute
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies
The primary objectives of this study are:
Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available
Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)
Read the detailed description
This is an open-label, expanded access study of KTE-X19 for the treatment of individuals with r/r B-cell malignancies. The study will consist of 2 cohorts as indicated below:
Cohort 1 will enroll individuals prior to commercial availability of KTE-X19 for the proposed indication.
Cohort 2 will enroll individuals after KTE-X19 becomes commercially available in cases when KTE-X19 does not meet commercial release specification(s).
The participants who received an infusion of KTE-X19 will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.
- Conditions
- Relapse/Refractory Mantle Cell Lymphoma
- Being tested
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide
- Medical subject headings
- Recurrence, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexucabtagene Autoleucel (KTE-X19)Biological
Also called Tecartus™
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
FludarabineDrug
Administered per package insert
CyclophosphamideDrug
Administered per package insert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse/Refractory Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162756
- Sponsor's protocol ID
- KT-US-472-0118
- Acronym
- ZUMA-18
- Status last verified
- Oct 2021
- First submitted
- 11 Nov 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT04162756
- Acronym / sponsor ID
- ZUMA-18 / KT-US-472-0118
- Conditions
- Relapse/Refractory Mantle Cell Lymphoma
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are:
Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available
Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)
Detailed description
This is an open-label, expanded access study of KTE-X19 for the treatment of individuals with r/r B-cell malignancies. The study will consist of 2 cohorts as indicated below:
Cohort 1 will enroll individuals prior to commercial availability of KTE-X19 for the proposed indication.
Cohort 2 will enroll individuals after KTE-X19 becomes commercially available in cases when KTE-X19 does not meet commercial release specification(s).
The participants who received an infusion of KTE-X19 will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- Relapsed or refractory disease, defined by the following:
- 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 or 1
Key exclusion criteria (8 listed)
- 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.
- History of detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or with a history of CNS lymphoma, CSF malignant cells, or brain metastases
- History 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
- Any medical condition that, as deemed by the treating physician, may interfere with assessment of safety or efficacy of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brexucabtagene Autoleucel (KTE-X19)Also: Tecartus™A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously. | Biological | – |
| FludarabineAdministered per package insert | Drug | – |
| CyclophosphamideAdministered per package insert | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide in people with Relapse/Refractory Mantle Cell Lymphoma, run by Kite, A Gilead Company at 9 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 25 inclusion and 8 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
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 14 Oct 2021.