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This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letetresgene autoleucel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letetresgene autoleucel | Drug | Letetresgene autoleucel will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval. | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response (TTR) | Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Stanford Hospital and Clinics |
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This study is a sub study of the master protocol (NCT03967223). The results presented are until the primary completion date. Data collection is still ongoing and additional results will be provided after study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Letetresgene Autoleucel (Lete-cel) | Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10^9 to 15×10^9 transduced T cells. |
| 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 | Nov 4, 2021 | Sep 18, 2023 |
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| Cyclophosphamide |
| Drug |
Cyclophosphamide will be used as a lymphodepleting chemotherapy. |
|
| Fludarabine | Drug | Fludarabine will be used as a lymphodepleting chemotherapy. |
|
| Up to approximately 54 months |
| Duration of Response (DOR) | Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease as assessed by local investigators, or death among participants with a confirmed response per RECIST 1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). | Up to approximately 54 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval. | Up to approximately 36 months |
| Progression Free Survival (PFS) | PFS is defined as the interval of time between from the date of T-cell infusion to the earliest date of radiological progression of disease (PD) as assessed by local investigator per RECIST v1.1, or death due to any cause. The PD is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. | Up to approximately 54 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. | Up to approximately 54 months |
| Number of Participants With AEs of Special Interest (AESIs) | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. | Up to approximately 54 months |
| Number of Participants With TEAEs and TESAEs by Severity | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. | Up to approximately 54 months |
| Number of Participants With AESIs by Severity | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. | Up to approximately 54 months |
| Percentage of Participants With Replication Competent Lentivirus (RCL) Positive | RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). | Up to approximately 54 months |
| Instances of Insertional Oncogenesis (IO) | Instances of Insertional Oncogenesis (IO) was summarized descriptively. | Up to approximately 54 months |
| Maximum Transgene Expansion (Cmax) | Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis. | Day 1 to Day 14 |
| Time to Cmax (Tmax) | Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis. | Day 1 to Day 14 |
| Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis. | Up to 28 days |
| Stanford |
| California |
| 94305 |
| United States |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Iowa College of Medicine | Iowa City | Iowa | 52242-1009 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02114 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Oncology Hematology | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering cancer center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Ohio State University-Columbus | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh, Hillman Cancer centre | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| University Of Texas Southwestern Medical Center | Dallas | Texas | 75390-8565 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9063 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| CIUSSS de L'Est-De-Lile-De-Montreal | Montreal | Quebec | H1T 2M4 | Canada |
| Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| Centre Léon Bérard | Lyon | 69373 | France |
| CHU de Bordeaux GH Sud Hôpital Haut Lévêque | Pessac | 33604 | France |
| Fondazione IRCCS Instituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| Ircss Istituto Clinico Humanitas | Romano di Lombardia | 20089 | Italy |
| The Netherlands Cancer Institute | Amsterdam | 1066 CX | Netherlands |
| Hospital Santa Creu Y Sant Pau | Barcelona | 08025 | Spain |
| Ico Duran y Reynals l'Hospitalet de Llobrega | Hospitalet de Llobregat, Barcelona | 08907 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Virgen Del Rocio | Seville | 41013 | Spain |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| University College Hospital-London | London | WC1E 6AG | United Kingdom |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Received T Cell Infusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Letetresgene Autoleucel (Lete-cel) | Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10^9 to 15×10^9 transduced T cells. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval. | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 36 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease as assessed by local investigators, or death among participants with a confirmed response per RECIST 1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) with a minimal 12 weeks (84 days ± 7 day window) duration relative to the total number of participants within the analysis population at the time of primary analysis as determined by local investigators per RECIST v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. The disease progression (PD) is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. 95% CI is based on Clopper-Pearson exact confidence interval. | Modified intent-to-treat (mITT) population included all participants who received any dose of Lete-cel. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 36 months |
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the interval of time between from the date of T-cell infusion to the earliest date of radiological progression of disease (PD) as assessed by local investigator per RECIST v1.1, or death due to any cause. The PD is defined as the date of radiological disease progression based on imaging data per RECIST v1.1. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs of Special Interest (AESIs) | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs and TESAEs by Severity | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs and SAEs were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AESIs by Severity | An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included cytokine release syndrome (CRS), hematopoietic cytopenias (including pancytopenia and aplastic anemia), graft vs host disease (GVHD), ICANS, Guillain-Barre syndrome, treatment-related inflammatory response at tumor site(s), and neutropenia Grade 4 lasting ≥28 days. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Replication Competent Lentivirus (RCL) Positive | RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G). | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Instances of Insertional Oncogenesis (IO) | Instances of Insertional Oncogenesis (IO) was summarized descriptively. | Not Posted | Jul 2026 | Up to approximately 54 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Maximum Transgene Expansion (Cmax) | Cmax was defined as maximum observed persistence, determined directly from the persistence-time data. Blood samples were collected for PK analysis. | Pharmacokinetic (PK) population included participants in the safety population from whom at least one persistence sample was obtained, analyzed and was measurable. | Posted | Geometric Mean | Geometric Coefficient of Variation | Copies per microgram genomic DNA | Day 1 to Day 14 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) | Tmax was defined as time to reach Cmax, determined directly from the persistence-time data. Blood samples were collected for PK analysis. | Pharmacokinetic (PK) population | Posted | Median | Full Range | Days | Day 1 to Day 14 |
|
| ||||||||||||||||||||||||||
| Secondary | Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28]) | Area under the persistence-time curve from time zero to Day 28. Blood samples were collected for PK analysis. | Pharmacokinetic (PK) population | Posted | Geometric Mean | Geometric Coefficient of Variation | Days*copies per microgram genomic DNA | Up to 28 days |
|
|
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to approximately 36 months. Data collection is still ongoing and additional results will be provided after study completion.
All-Cause mortality, Non-SAEs and SAEs were collected for intent-to-treat population that included all participants who started leukapheresis procedure.
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 | Letetresgene Autoleucel (Lete-cel) | Eligible participants were leukapheresed to manufacture autologous lete-cel. Participants underwent lymphodepleting chemotherapy which generally consisted of fludarabine 30 mg/m^2/day on day -7 through day -4 and cyclophosphamide 900 milligrams per meter square per day (mg/m^2/day) on day -6 through day -4. followed by a single infusion of lete-cel on Day 1. The dose of lete-cel was within the range of 1×10^9 to 15×10^9 transduced T cells. | 1 | 7 | 4 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinitis | 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 fibrinogen 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 |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Catheter site phlebitis | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | 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 |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2022 | Sep 18, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| United States |
|
|
|
|
|
|