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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005009-35 | EudraCT Number |
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The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).
Bridging therapy could be administered at the discretion of the investigator and is recommended for participants with high disease burden at baseline (M3 marrow [> 25% leukemic blasts] or ≥ 1,000 blasts/mm^3 in the peripheral circulation) to control participant's disease prior to conditioning chemotherapy. Bridging therapy includes:
Attenuated VAD: Vincristine non-liposomal (1-2 mg IV weekly) or liposomal (2.25 mg/m^2 IV weekly), and dexamethasone 20-40 mg IV or oral administration (PO) daily x 3-4 days per week. Optional doxorubicin 50 mg/m^2 IV x 1 (first week only).
Mercaptopurine (6-MP): 50-75 mg/m^2/day by mouth (administer at bedtime on an empty stomach to improve absorption).
Hydroxyurea: Doses titrated between 15-50 mg/kg/day (rounded to the nearest 500 mg capsule and given as a single daily oral dose on a continuous basis).
DOMP: Dexamethasone 6 mg/m^2/day PO (or IV) divided twice daily (BID) Days 1-5, vincristine 1.5 mg/m^2 (maximum dose 2 mg) IV on Day 1, methotrexate 20 mg/m^2 PO weekly, 6-MP 50- 75mg/m^2/day PO daily.
Attenuated FLAG/FLAG-IDA: fludarabine 30 mg/m^2 IV days 1-2, cytarabine 2 g/m^2 IV days 1-2, G-CSF 5 μg/kg subcutaneously (SC) or IV starts on Day 3 and can continue until day before the start of conditioning chemotherapy. With or without idarubicin 6 mg/m^2 IV Days 1-2.
Mini-hyper CVAD (courses A and/or B):
After completion of the Month 24 visit, subjects who received an infusion of KTE-X19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Experimental | Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) will receive conditioning chemotherapy (fludarabine 25 mg/m^2 intravenously [IV] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered. |
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| Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Experimental | Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered. |
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| Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | Experimental | Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brexucabtagene autoleucel | Biological | A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | DLT is drug-related events with onset within first 28 days following infusion:
| First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation |
| Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid[CSF]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses >1.5 cm in greatest transverse diameter[GTD] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm[long axis] and >1.0 cm[short axis] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt<100000/μL or ANC<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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Key Inclusion Criteria:
Relapsed or refractory B-precursor ALL defined as one of the following:
Morphological disease in the bone marrow (≥ 5% blasts)
Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Adequate renal, hepatic, pulmonary and cardiac function defined as:
In individuals previously treated with blinatumomab, cluster of differentiation 19 (CD19) tumor expression in bone marrow or peripheral blood.
Key Exclusion Criteria:
Diagnosis of Burkitt's leukemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
Isolated extramedullary disease
Central nervous system (CNS) abnormalities
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
Primary immunodeficiency
Known infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive) or hepatitis C virus.
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Prior medication:
Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by International Bone Marrow Transplant Registry (IBMTR) index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
Live vaccine ≤ 4 weeks prior to enrollment
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
Individuals of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of brexucabtagene autoleucel (KTE-X19)
In the investigators judgment, the individuals is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
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 |
|---|---|---|---|---|---|---|
| UC San Diego-Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| University of California Los Angeles (UCLA) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Oluwole OO, Shah BD, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia Treated with Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy [Abstract S1569]. The 23rd European Hematology Association (EHA) Congress 2018 14-17 June; Stockholm, Sweden. | ||
| Result | Sabatino M, Choi K, Chiruvolu V, Better M. Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 711]. Blood 2016;128 (22):1227. | ||
| Result | Shah B, Castro J, Gokbuget N, Kersten MJ, Hagenbeek T, Wierda W, et al. ZUMA-3: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of KTE-C19 Anti-CD19 CAR T Cells in Adult Subjects with Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (r/r ALL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3713. | ||
| Result | Shah B, Huynh V, Sender LS, Lee DW, Castro JE, Wierda WG, et al. High Rates of Minimal Residual Disease-Negative (MRD-) Complete Responses (CR) in Adult and Pediatric and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials. Blood 2016;128 (22):2803. | ||
| Result | Shah B, Stock W, Wierda W, Topp M, Kersten MJ, Houot R, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T cell Therapy in Adult Patients (Pts) With Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial: Preliminary Results of Novel Safety Interventions [Abstract ALL-025]. Clinical lymphoma, myeloma & leukemia 2017;17:S253. |
| 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#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
173 participants were screened. Bridging therapy was recommended for all participants particularly those participants with high disease burden at baseline (M3 marrow [> 25% leukemic blasts] or ≥ 1,000 blasts/mm^3 in the peripheral circulation) to control participant's disease post apheresis/enrollment and prior to conditioning chemotherapy.
Participants were enrolled at study sites in France, Germany, the Netherlands, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) received conditioning chemotherapy (fludarabine 25 mg/m^2 intravenously [IV] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| 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: Amendment 6 | Oct 31, 2018 | Aug 24, 2021 |
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| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Experimental | Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight will be administered. |
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| Cyclophosphamide | Drug | Administered intravenously. |
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| Fludarabine | Drug | Administered intravenously. |
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| Phase 2: Complete Remission (CR) Rate Per Independent Review | CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt < 100000/µL or ANC < 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Phase 2: Duration of Remission (DOR) Per Independent Review | DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with < 5 white blood cells [WBCs] per mm^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses. | From first CR or CRi (Phase 2) up to 3.7 years |
| Phase 2: OCR Rate (CR + CRi) Per Investigator Review | OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt <100000/µL or ANC <1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
| Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
| Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt < 100000/µL or ANC < 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Phase 2: Overall Survival (OS) | OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
| Phase 2: Relapse-free Survival (RFS) | RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses. | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
| Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion. | Up to 5 years |
| Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Up to 5 years |
| Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Grading categories are determined by CTCAE version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Up to 5 years |
| Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies | First infusion date of brexucabtagene autoleucel (Phase 2) up to 2.7 years |
| Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | The EQ-5D-5 levels(EQ-5D-5L)is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal.It is a self-reported questionnaire used to assess the overall health status of participant scoring 5 dimensions of health: mobility,self-care,usual activities,pain/discomfort and anxiety/depression.Each dimension has 5 levels:no problems,slight problems,moderate problems,severe problems,and extreme problems.EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by a formula that attaches values (called QOL utilities)to each of the levels in each dimension.EQ-5D Summary Index values range from -0.11(worst health) to 1.00(perfect health).This decision results in a 1-digit number that shows the level for that dimension. The digits for 5 dimensions can be combined to 5-digit number that show the participant's health.Higher scores of EQ-5D-5L indicate better health. | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 |
| Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state. | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| H Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Loyola University | Chicago | Illinois | 60153 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of MD Greenbaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai Tisch Cancer Institute | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester | New York | New York | 14642 | United States |
| Sarah Cannon | Nashville | Tennessee | 37203 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Seattle Cancer Center | Seattle | Washington | 98109 | United States |
| University Health Network - Princess Margaret | Toronto | Ontario | M5G 2M9 | Canada |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Haut-Leveque | Pessac | 33604 | France |
| Hopital Pontchaillou - CHU de Rennes - Service d'Hematologie | Rennes | 35033 | France |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Klinikum der Universitat Munchen | München | 81377 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| Erasmus MC | Rotterdam | 3015 CE | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3508 GA | Netherlands |
| Result | Shah B, Stock W, Wierda W, Topp MS, Kersten MJ, Houot R, et al. Preliminary Results of Novel Safety Interventions in Adult Patients (Pts) With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial. European Society for Medical Oncology (ESMO) Congress 2017. |
| Result | Shah B, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. KTE-C19 Chimeric Antigen Receptor (CAR) T Cell Therapy in Adults with High-Burden Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL): Updated Results from Phase 1/2 of ZUMA-3 [Abstract P523]. The 22nd European Hematology Association (EHA) Congress 2017 22-25 June; Madrid, Spain. |
| Result | Shah BD, Bishop MR, Oluwole OO, Logan A, Baer MR, Donnellan WB, et al. End of Phase I Results of ZUMA-3, A Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients (pts) with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract]. J Clin Oncol 2019;37 (15):7006. |
| Result | Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia: End of Phase 1 Results of ZUMA-3 [Abstract PS945]. HemaSphere 2019;3 (S1):426. |
| Result | Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL): Outcomes in Patients Who Were Treated with Prior Blinatumomab in ZUMA-3 [Abstract ALL-128]. Clinical lymphoma, myeloma & leukemia 2018;18 (Supplement 1):S184. |
| Result | Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients Treated With Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. ASCO; 2018 01-05 June; Chicago, IL. |
| Result | Shah BD, Stock W, Wierda WG, Oluwole O, Holmes H, Schiller GJ, et al. Phase 1 Results of ZUMA-3: KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 612]. Blood 2017;130 (Supplement 1):888. |
| Result | Shah BD, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. Updated results from ZUMA- 3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL) [Abstract 3024]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2017 02-06 June; Chicago, Illinois. |
| Result | Wierda WG, Bishop MR, Oluwole O, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract 256]. Biol Blood Marrow Transplant 2019;25 (3):S185. |
| Result | Wierda WG, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract]. Blood 2018;132 (Supplement 1):897. |
| 33827116 | Result | Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, O'Dwyer KM, Holmes H, Arellano ML, Ghobadi A, Pagel JM, Lin Y, Cassaday RD, Park JH, Abedi M, Castro JE, DeAngelo DJ, Malone AK, Mawad R, Schiller GJ, Rossi JM, Bot A, Shen T, Goyal L, Jain RK, Vezan R, Wierda WG. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021 Jul 8;138(1):11-22. doi: 10.1182/blood.2020009098. |
| 34097852 | Result | Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Feng C, Dong J, Shen T, Milletti F, Rossi JM, Vezan R, Masouleh BK, Houot R. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021 Aug 7;398(10299):491-502. doi: 10.1016/S0140-6736(21)01222-8. Epub 2021 Jun 4. |
| 36494725 | Derived | Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Dong J, Adhikary S, Zhou L, Schuberth PC, Faghmous I, Masouleh BK, Houot R. Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study. J Hematol Oncol. 2022 Dec 10;15(1):170. doi: 10.1186/s13045-022-01379-0. |
| 35727476 | Derived | Shah BD, Smith NJ, Feng C, Jeyakumar S, Castaigne JG, Faghmous I, Masouleh BK, Malone DC, Bishop MR. Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States. Adv Ther. 2022 Aug;39(8):3678-3695. doi: 10.1007/s12325-022-02201-6. Epub 2022 Jun 21. |
| FG001 | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| FG002 | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| FG003 | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| BG001 | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| BG002 | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| BG003 | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | DLT is drug-related events with onset within first 28 days following infusion:
| DLT-Evaluable Analysis Set included first 3 participants in Phase 1 treated with target brexucabtagene autoleucel dose and followed for at least 28 days. Only participants from Phase 1: 2 X 10^6 Anti-CD19 CAR T Cells/kg were pre-specified to be assessed for this Outcome Measure. | Posted | Number | percentage of participants | First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation |
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| Primary | Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid[CSF]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses >1.5 cm in greatest transverse diameter[GTD] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm[long axis] and >1.0 cm[short axis] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt<100000/μL or ANC<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method. | The modified Intent-to-Treat (mITT) Analysis Set included all enrolled participants treated with brexucabtagene autoleucel in Phase 2. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Complete Remission (CR) Rate Per Independent Review | CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt < 100000/µL or ANC < 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Duration of Remission (DOR) Per Independent Review | DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with < 5 white blood cells [WBCs] per mm^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses. | Participants in mITT Analysis Set with overall complete remission (CR or CRi ) were analyzed. | Posted | Median | 95% Confidence Interval | months | From first CR or CRi (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: OCR Rate (CR + CRi) Per Investigator Review | OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt <100000/µL or ANC <1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
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| Secondary | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | Participants in mITT Analysis Set were analyzed. | Posted | Number | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
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| Secondary | Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses > 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and > 1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set with CR were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt < 100000/µL or ANC < 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses >1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm [long axis] and >1.0 cm [short axis] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. | Participants in mITT Analysis Set with CRi were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Overall Survival (OS) | OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses. | Participants in mITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years |
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| Secondary | Phase 2: Relapse-free Survival (RFS) | RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses. | Participants in mITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years |
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| Secondary | Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion. | The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. | Posted | Number | percentage of participants | Up to 5 years |
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| Secondary | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Participants in Safety Analysis Set were analyzed. | Posted | Count of Participants | Participants | No | Up to 5 years |
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| Secondary | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Grading categories are determined by CTCAE version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Participants in Safety Analysis Set were analyzed. | Posted | Count of Participants | Participants | No | Up to 5 years |
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| Secondary | Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies | Participants in Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 2.7 years |
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| Secondary | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | The EQ-5D-5 levels(EQ-5D-5L)is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal.It is a self-reported questionnaire used to assess the overall health status of participant scoring 5 dimensions of health: mobility,self-care,usual activities,pain/discomfort and anxiety/depression.Each dimension has 5 levels:no problems,slight problems,moderate problems,severe problems,and extreme problems.EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by a formula that attaches values (called QOL utilities)to each of the levels in each dimension.EQ-5D Summary Index values range from -0.11(worst health) to 1.00(perfect health).This decision results in a 1-digit number that shows the level for that dimension. The digits for 5 dimensions can be combined to 5-digit number that show the participant's health.Higher scores of EQ-5D-5L indicate better health. | Participants in Safety Analysis Set with available data were analyzed. | Posted | Count of Participants | Participants | No | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 |
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| Secondary | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state. | Participants in Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 |
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Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel.
All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
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 | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. | 6 | 6 | 6 | 6 | 6 | 6 |
| EG001 | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. | 17 | 28 | 21 | 23 | 23 | 23 |
| EG002 | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 0.5 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. | 15 | 20 | 12 | 16 | 16 | 16 |
| EG003 | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing > 100 kg, a maximum flat dose of 1 x 10^8 anti-CD19 CAR T cells/kg of body weight was administered. | 39 | 71 | 41 | 55 | 55 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tongue oedema | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Herpes simplex viraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Osteomyelitis fungal | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone marrow reticulin fibrosis | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gravitational oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Acidosis hyperchloraemic | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Brain fog | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| CRS | Immune system disorders | MedDRA (26.1) | 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 |
| Prot | Yes | No | No | Study Protocol: Amendment 7 | Dec 14, 2021 | Sep 30, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2020 | Aug 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705347 | brexucabtagene autoleucel |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| 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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Not collected |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other or More Than One Race |
|
| Not collected |
|
| Native Hawaiian or Other Pacific Islander |
|
| Germany |
|
| Netherlands |
|
| United States |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
|
|
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| Participants |
|
|