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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01861 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10373 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Swedish Orphan Biovitrum | INDUSTRY |
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This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell non-Hodgkin lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy may be complicated by two potentially life-threatening side effects: CRS and neurotoxicity. Anakinra is a drug typically used to treat rheumatoid arthritis, but may also help in preventing CAR-T cell-related cytokine release syndrome and neurotoxicity.
OUTLINE:
Patients receive anakinra intravenously (IV) [previously subcutaneously (SC) for some patients] over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Patients should also undergo at screening an x-ray, positron emission tomography/computed tomography (PET/CT) or CT, bone marrow aspirate (BMA) and biopsy (if clinically indicated), and lumbar puncture (if clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study.
After completion of lisocabtagene maraleucel infusion, patients are followed up periodically for up to 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (anakinra, lisocabtagene maraleucel) | Experimental | Patients receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Patients should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Biological | Given IV (previously SC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Absence of Any Grade Cytokine Release Syndrome (CRS) | Will assess the efficacy of anakinra in preventing the occurrence of any grade CRS using the Bayesian optimal phase 2 design. Assessed based on the ASTCT Consensus Grading for CRS and Neurotoxicity Associated with Immune Effector Cell. | Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion |
| Measure | Description | Time Frame |
|---|---|---|
| CRS Grade | CRS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019) based on the presence and severity of fever, hypotension, and hypoxia: grade 1, fever ≥38°C without hypotension or hypoxia; grade 2, hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; grade 3, hypotension requiring a single vasopressor or hypoxia requiring high-flow oxygen; grade 4, life-threatening hypotension requiring multiple vasopressors and/or hypoxia requiring positive-pressure ventilation; grade 5, death. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the principal investigator (PI)
Known hypersensitivity to Escherichia € coli-derived proteins, anakinra, or to any component of the product
Major organ dysfunction defined as:
Uncontrolled serious and active infection
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Gauthier | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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Of 27 enrolled participants, 25 met inclusion criteria and started treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevention (anakinra, lisocabtagene maraleucel) | Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2024 |
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| X-Ray Imaging | Procedure | Undergo x-ray |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| Computed Tomography | Procedure | Undergo PET/CT or CT |
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| Bone Marrow Aspiration | Procedure | Undergo BMA |
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| Bone Marrow Biopsy | Procedure | Undergo bone marrow biopsy |
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| Lumbar Puncture | Procedure | Undergo lumbar puncture |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Up to 28 days after liso-cel infusion |
| ICANS Grade | ICANS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019): grade 1, immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously; grade 2, ICE score 3-6, awakens to voice; grade 3, ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging; grade 4, ICE 0, unarousable and unable to perform ICE, unarousable or requires vigorous or repetitive tactile stimuli to arouse, stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging, decerebrate or decorticate posturing, or cranial nerve VI | Up to 28 days after liso-cel infusion |
| Rate of Hospitalization After Liso-cel Treatment | Number of patients hospitalized after liso-cel treatment. | Up to 28 days after liso-cel infusion |
| Duration of Hospitalization After Liso-cel Treatment | Duration of hospitalization measured in days following liso-cel administration. | Up to 28 days after liso-cel infusion |
| Corticosteroid Usage After Liso-cel Treatment | Number of patients who received corticosteroids within 28 days after liso-cel infusion. | Up to 28 days after liso-cel infusion |
| Disease Response to Liso-cel | Best response within approximately 90 days post liso-cel infusion will be assessed based on institutional standard using physical examination, imaging (CT or PET-CT), and if necessary, bone marrow biopsies, in patients with measurable disease prior to treatment. | Approximately 90 days after liso-cel infusion |
| Adverse Events (AEs) | Grade 3 or greater AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. | Up to 28 days after liso-cel infusion |
| COMPLETED |
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| NOT COMPLETED |
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Two participants who were enrolled but not treated are included in the baseline analysis population description.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevention (anakinra, lisocabtagene maraleucel) | Patients receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Patients should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection |
| Units | Counts |
|---|---|
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Absence of Any Grade Cytokine Release Syndrome (CRS) | Will assess the efficacy of anakinra in preventing the occurrence of any grade CRS using the Bayesian optimal phase 2 design. Assessed based on the ASTCT Consensus Grading for CRS and Neurotoxicity Associated with Immune Effector Cell. | Not applicable here (no difference between number of participants analyzed | Posted | Count of Participants | Participants | Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion |
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| Secondary | CRS Grade | CRS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019) based on the presence and severity of fever, hypotension, and hypoxia: grade 1, fever ≥38°C without hypotension or hypoxia; grade 2, hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; grade 3, hypotension requiring a single vasopressor or hypoxia requiring high-flow oxygen; grade 4, life-threatening hypotension requiring multiple vasopressors and/or hypoxia requiring positive-pressure ventilation; grade 5, death. | Posted | Count of Participants | Participants | Up to 28 days after liso-cel infusion |
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| Secondary | ICANS Grade | ICANS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019): grade 1, immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously; grade 2, ICE score 3-6, awakens to voice; grade 3, ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging; grade 4, ICE 0, unarousable and unable to perform ICE, unarousable or requires vigorous or repetitive tactile stimuli to arouse, stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging, decerebrate or decorticate posturing, or cranial nerve VI | Posted | Count of Participants | Participants | Up to 28 days after liso-cel infusion |
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| Secondary | Rate of Hospitalization After Liso-cel Treatment | Number of patients hospitalized after liso-cel treatment. | Posted | Count of Participants | Participants | Up to 28 days after liso-cel infusion |
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| Secondary | Duration of Hospitalization After Liso-cel Treatment | Duration of hospitalization measured in days following liso-cel administration. | The number of days in the hospital (hospitalized only) group only included patients who were hospitalized (n=18) | Posted | Median | Inter-Quartile Range | days | Up to 28 days after liso-cel infusion |
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| Secondary | Corticosteroid Usage After Liso-cel Treatment | Number of patients who received corticosteroids within 28 days after liso-cel infusion. | Posted | Count of Participants | Participants | Up to 28 days after liso-cel infusion |
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| Secondary | Disease Response to Liso-cel | Best response within approximately 90 days post liso-cel infusion will be assessed based on institutional standard using physical examination, imaging (CT or PET-CT), and if necessary, bone marrow biopsies, in patients with measurable disease prior to treatment. | Six patients were not evaluable for this endpoint due to lack of measurable disease prior to treatment. | Posted | Count of Participants | Participants | Approximately 90 days after liso-cel infusion |
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| Secondary | Adverse Events (AEs) | Grade 3 or greater AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. | Posted | Count of Participants | Participants | Up to 28 days after liso-cel infusion |
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All-Cause Mortality was assessed from date of infusion to date off study, up to 32 months; serious adverse events and other (not including serious) adverse events were assessed from the date of consent until stabilization or resolution, up to 36 days after infusion of liso-cel.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevention (anakinra, lisocabtagene maraleucel) | Participants receive anakinra IV (previously SC) over 10-30 minutes daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Participants should also undergo at screening an x-ray, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Participants also undergo blood sample collection on study. Anakinra: Given IV (previously SC) X-Ray Imaging: Undergo x-ray Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT or CT Bone Marrow Aspiration: Undergo BMA Bone Marrow Biopsy: Undergo bone marrow biopsy Lumbar Puncture: Undergo lumbar puncture Biospecimen Collection: Undergo blood sample collection | 10 | 25 | 15 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Other | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Immune effector cell-associated neurotoxicity syndrome |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocyte count increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Other | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Immune effector cell-associated neurotoxicity syndrome |
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| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dysphasia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fibrinogen decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Hallucinations | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Gauthier | Fred Hutchinson Cancer Center | 206-667-2713 | jgauthier@fredhutch.org |
| Sep 15, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2024 | Nov 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D019947 | Receptors, Interleukin-6 |
| D014965 | X-Rays |
| D019047 | Phantoms, Imaging |
| D009682 | Magnetic Resonance Spectroscopy |
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D018123 | Receptors, Interleukin |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D004864 | Equipment and Supplies |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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