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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004803-11 | EudraCT Number |
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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.
Following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (Study KT-US-982-5968). Participants will complete the remainder of the 15-year follow-up assessments in the KT-US-982-5968 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axicabtagene Ciloleucel and Rituximab Combination | Experimental | Participants will receive rituximab 375 mg/m^2, once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m^2 over 30 minutes and cyclophosphamide 500 mg/m^2 over 60 minutes) once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg once on Day 0 and additional rituximab 375 mg/m^2 of 5 doses, once every 28 days starting from Day 21 up to Day 133. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | A single infusion of CAR-transduced autologous T cells administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators | CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method. | First infusion date up to maximum duration of 32.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion. |
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Key Inclusion Criteria:
Histologically confirmed large B-cell lymphoma
Chemotherapy-refractory disease, defined as one or more of the following:
At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
Individuals must have received adequate prior therapy, including at a minimum:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate renal, hepatic, pulmonary, and cardiac function
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41492094 | Derived | Strati P, Leslie L, Shiraz P, Budde LE, Oluwole OO, Ulrickson M, Ramakrishnan A, Zhang T, Sun J, Milletti F, Kanska J, Shen R, Neumann F, Xu H, Patel K. Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial. Nat Cancer. 2026 Feb;7(2):304-315. doi: 10.1038/s43018-025-01102-1. Epub 2026 Jan 5. | |
| 34515338 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
36 participants were screened.
Participants were enrolled at study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Axicabtagene Ciloleucel and Rituximab Combination | Participants received rituximab 375 mg/m^2 intravenously (IV) once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m^2 over 30 minutes and cyclophosphamide 500 mg/m^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2022 | Dec 5, 2023 |
Not provided
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|
| Rituximab | Drug | Administered intravenously |
|
|
| Fludarabine | Drug | Administered according to package insert |
|
| Cyclophosphamide | Drug | Administered according to package insert |
|
| First infusion date up to maximum duration of 27 months |
| Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented. | First infusion date up to maximum duration of 27 months |
| Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators | ORR: percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal; no new sites. | First infusion date up to maximum duration of 32.7 months |
| Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators | DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression [progressive metabolic disease (PMD); progressive radiologic disease (PRD)] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported. | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months) |
| Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported. | First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months) |
| Overall Survival (OS) | OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported. | First infusion date up to death regardless of cause (up to approximately 32.7 months) |
| Peak Level of Anti-CD19 CAR T Cells in Blood | Peak was defined as the maximum number of CAR T cells in blood measured after infusion. | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
| Level of Anti-CD19 CAR T Cells in Blood by Visit | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
| Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) | AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28. | Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28 |
| Time to Peak Level of Anti-CD19 CAR T Cells in Blood | Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion. | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
| Duarte |
| California |
| 91010-3012 |
| United States |
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States |
| UCLA Hematology/Oncology | Santa Monica | California | 90404 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Columbia University Medical Center, New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
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| ID | Title | Description |
|---|---|---|
| BG000 | Axicabtagene Ciloleucel and Rituximab Combination | Participants received rituximab 375 mg/m^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m^2 over 30 minutes and cyclophosphamide 500 mg/m^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators | CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method. | Modified intent-to-treat (mITT) analysis set included all enrolled participants who were treated with the target dose of axicabtagene ciloleucel and at least 1 dose of rituximab after axicabtagene ciloleucel infusion. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date up to maximum duration of 32.7 months |
|
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| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion. | Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel. | Posted | Number | percentage of participants | First infusion date up to maximum duration of 27 months |
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| Secondary | Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented. | Participants in the safety analysis set were analyzed. | Posted | Number | percentage of participants | First infusion date up to maximum duration of 27 months |
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| Secondary | Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators | ORR: percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal; no new sites. | Participants in the mITT analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date up to maximum duration of 32.7 months |
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| Secondary | Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators | DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression [progressive metabolic disease (PMD); progressive radiologic disease (PRD)] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported. | Participants in the mITT analysis set with an objective response (CR+PR) were analyzed. | Posted | Median | 95% Confidence Interval | months | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months) |
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| Secondary | Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately > liver), 5 (uptake markedly > liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi >1.5 cm; ≥ 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions >2 cm; spleen increased by >50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported. | Participants in the mITT analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported. | Participants in the mITT analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | First infusion date up to death regardless of cause (up to approximately 32.7 months) |
|
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| Secondary | Peak Level of Anti-CD19 CAR T Cells in Blood | Peak was defined as the maximum number of CAR T cells in blood measured after infusion. | Participants in the safety analysis set were analyzed. | Posted | Median | Full Range | cells per microliter (cells/µL) | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Level of Anti-CD19 CAR T Cells in Blood by Visit | Participants in the safety analysis set with available data were analyzed. | Posted | Median | Full Range | cells/µL | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
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| Secondary | Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) | AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28. | Participants in the safety analysis set were analyzed. | Posted | Median | Full Range | cells/μL*days | Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28 |
|
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| Secondary | Time to Peak Level of Anti-CD19 CAR T Cells in Blood | Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion. | Participants in the safety analysis set were analyzed. | Posted | Median | Full Range | days | Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24 |
|
|
All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months
All-cause mortality: All enrolled analysis set included all the enrolled participants.
Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Axicabtagene Ciloleucel and Rituximab Combination | Participants received rituximab 375 mg/m^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m^2 over 30 minutes and cyclophosphamide 500 mg/m^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133. | 11 | 27 | 14 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Jan 29, 2021 | Nov 24, 2023 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Translational Statistical Analysis Plan | Jun 25, 2021 | Nov 24, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
| D000069283 | Rituximab |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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