Condition or disease | Intervention/treatment | Phase |
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Refractory Large B-cell Lymphoma | Biological: Axicabtagene Ciloleucel Drug: Rituximab Drug: Fludarabine Drug: Cyclophosphamide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14) |
Actual Study Start Date : | November 5, 2019 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2036 |
Arm | Intervention/treatment |
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Experimental: Axicabtagene Ciloleucel and Rituximab Combination
Participants will receive rituximab, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional rituximab.
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Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
Other Name: Yescarta®
Drug: Rituximab Administered intravenously
Other Name: RITUXAN®
Drug: Fludarabine Administered according to package insert
Drug: Cyclophosphamide Administered according to package insert
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Chemotherapy-refractory disease, defined as one or more of the following:
Individuals must have received adequate prior therapy, including at a minimum:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
United States, Arizona | |
Banner MD Anderson Cancer Center | |
Gilbert, Arizona, United States, 85234 | |
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010-3012 | |
Stanford Cancer Institute | |
Palo Alto, California, United States, 94305 | |
UCLA Hematology/Oncology | |
Santa Monica, California, United States, 90404 | |
United States, Florida | |
Mayo Clinic Florida | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
John Theurer Cancer Center at Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Columbia University Medical Center, New York Presbyterian Hospital | |
New York, New York, United States, 10032 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
St. David's South Austin Medical Center | |
Austin, Texas, United States, 78704 | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Swedish Cancer Institute | |
Seattle, Washington, United States, 98104 |
Study Director: | Kite Study Director | Kite, A Gilead Company |
Tracking Information | |||||
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First Submitted Date ICMJE | June 27, 2019 | ||||
First Posted Date ICMJE | June 28, 2019 | ||||
Last Update Posted Date | March 25, 2021 | ||||
Actual Study Start Date ICMJE | November 5, 2019 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Complete Response (CR) Rate [ Time Frame: Up to 2 years ] CR rate is defined as the incidence of a CR per the Lugano Classification as determined by study investigators.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma | ||||
Official Title ICMJE | A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14) | ||||
Brief Summary | The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Refractory Large B-cell Lymphoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Axicabtagene Ciloleucel and Rituximab Combination
Participants will receive rituximab, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional rituximab.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
27 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Estimated Study Completion Date ICMJE | June 2036 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04002401 | ||||
Other Study ID Numbers ICMJE | KT-US-471-0114 2019-004803-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Gilead Sciences | ||||
Study Sponsor ICMJE | Gilead Sciences | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Gilead Sciences | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |